Page last updated: 2024-12-04

pyridoxal

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Pyridoxal is an aldehyde form of vitamin B6. It is a crucial cofactor for over 140 enzymatic reactions in the human body, primarily involved in amino acid metabolism. Pyridoxal is synthesized from glucose through a series of enzymatic steps. It is essential for various biological processes, including:
- **Neurotransmitter synthesis:** Pyridoxal is involved in the synthesis of neurotransmitters such as dopamine, serotonin, and GABA, which play crucial roles in brain function and mood regulation.
- **Glycogen metabolism:** It participates in the breakdown of glycogen, the stored form of glucose, providing energy for the body.
- **Hemoglobin synthesis:** Pyridoxal is required for the synthesis of heme, a component of hemoglobin, which transports oxygen in the blood.
- **Immune function:** It contributes to the proper functioning of the immune system by supporting the production of antibodies.
- **DNA and RNA synthesis:** Pyridoxal plays a role in the synthesis of DNA and RNA, essential for cell growth and replication.
Pyridoxal deficiency can lead to various health issues, including anemia, seizures, and neurological disorders. It is studied extensively to understand its role in different metabolic pathways and its potential applications in treating diseases. Research focuses on its involvement in neurological disorders, such as Parkinson's disease and Alzheimer's disease, as well as its potential to prevent and manage cardiovascular diseases.'

Cross-References

ID SourceID
PubMed CID1050
CHEMBL ID102970
CHEBI ID17310
SCHEMBL ID29906
MeSH IDM0018240

Synonyms (60)

Synonym
nsc 19613
einecs 200-630-8
brn 0383768
3-hydroxy-5-hydroxymethyl-2-methyl-4-pyridincarbaldehyd
3-hydroxy-5-(hydroxymethyl)-2-methylpyridine-4-carbaldehyde
CHEBI:17310 ,
aids006783
aids-006783
pyridoxaldehyde
nsc19613
4-pyridinecarboxaldehyde, 3-hydroxy-5-(hydroxymethyl)-2-methyl-
3-hydroxy-5-(hydroxymethyl)-2-methyl-pyridine-4-carbaldehyde
OPREA1_534980 ,
PYRIDOXAL ,
C00250
66-72-8
3-hydroxy-5-(hydroxymethyl)-2-methylisonicotinaldehyde
3-hydroxy-5-(hydroxymethyl)-2-methylpyridine-4-carboxaldehyde
DB00147
NCGC00142580-04
piridoxal
2-methyl-3-hydroxy-4-formyl-5-hydroxymethylpyridine
NCGC00142580-03
3-hydroxy-5-(hydroxymethyl)-2-methyl-4-pyridinecarboxaldehyde
NCGC00142580-01
NCHEMBIO.93-COMP2 ,
849ADF16-456D-4BAB-A7EA-93A4C9D428AF
BMSE000110
4-pyridinecarboxaldehyde, 3-hydroxy-5-(hydroxymethyl)-2-methyl- (9ci)
CHEMBL102970
AKOS000634540
STL137770
BBL004877
5-21-13-00044 (beilstein handbook reference)
3thm379k8a ,
unii-3thm379k8a
tox21_111561
cas-66-72-8
dtxsid4046020 ,
dtxcid2026020
bdbm50366979
MLS003876810
smr002533344
6-methyl-1,3-dihydro-furo[3,4-c]pyridine-1,7-diol
pyridoxal [mi]
1,3-dihydro-6-methylfuro[3,4-c]pyridine-1,7-diol
pyridoxal [who-dd]
SCHEMBL29906
tox21_111561_1
NCGC00142580-05
3-hydroxy-5-(hydroxymethyl)-2-methylisonicotinaldehyde #
EX-A576
pyridocalx
GS-3388
Q3065731
Z56922082
D82489
EN300-24934
AS-83252
CS-0028583

Research Excerpts

Overview

Pyridoxal 5'-phosphate is a competitive inhibitor of DNA substrate but not of ATP.

ExcerptReferenceRelevance
"Pyridoxal is a poor coenzyme, but readily released from the enzyme."( A simple method for determination of stereospecificity of aminotransferases for C-4' hydrogen transfer of the coenzyme.
Esaki, N; Ito, J; Nishimura, K; Soda, K; Yoshimura, T, 1994
)
1.01
"Pyridoxal 5'-phosphate is a competitive inhibitor of DNA substrate but not of ATP."( Inhibition of the recBC enzyme of Escherichia coli by specific binding of pyridoxal 5'-phosphate to DNA binding site.
Anai, M; Fujiyoshi, T; Nakayama, J; Takagi, Y, 1979
)
1.21

Effects

Pyridoxal kinase has been purified 2000-fold from pig brain.

ExcerptReferenceRelevance
"Pyridoxal has a role in immunological competence, and it is possible that the increased incidence of urinary tract infection in patients with diabetes reflects impaired immunological competence due to pyridoxal deficiency."( The association of bacteriuria and reduced serum pyridoxal concentrations in patients with diabetes mellitus.
Davis, RE; Goodwin, CS; McCann, VJ; Ormonde, NW, 1981
)
1.24
"Pyridoxal has a role in immunological competence, and it is possible that the increased incidence of urinary tract infection in patients with diabetes reflects impaired immunological competence due to pyridoxal deficiency."( The association of bacteriuria and reduced serum pyridoxal concentrations in patients with diabetes mellitus.
Davis, RE; Goodwin, CS; McCann, VJ; Ormonde, NW, 1981
)
1.24
"Pyridoxal kinase has been purified 2000-fold from pig brain. "( Brain pyridoxal kinase. Mobility of the substrate pyridoxal and binding of inhibitors to the nucleotide site.
Churchich, JE; Kwok, F, 1979
)
2.18

Actions

ExcerptReferenceRelevance
"Pyridoxal levels were lower in schizophrenia and increased according to the clinical course of the illness."( Significance of measurements of peripheral carbonyl stress markers in a cross-sectional and longitudinal study in patients with acute-stage schizophrenia.
Arai, H; Hanzawa, R; Higa, M; Higashiyama, R; Hotta, Y; Katsuta, N; Maeshima, H; Nakamura, T; Nishimon, S; Ohnuma, T; Sannohe, T; Shibata, N; Takebayashi, Y; Takeda, M, 2014
)
1.12

Treatment

ExcerptReferenceRelevance
"Pretreatment with pyridoxal hydrochloride resulted in significantly higher corneal stiffening after CXL. "( The role of nonenzymatic glycation and carbonyls in collagen cross-linking for the treatment of keratoconus.
Brummer, G; Conrad, GW; Littlechild, S; McCall, S; Zhang, Y, 2011
)
0.7

Toxicity

ExcerptReferenceRelevance
" The LD50 values of PIH in both species were 5 and 1 g/kg given orally and intraperitoneally, respectively."( Toxicological study of pyridoxal isonicotinoyl hydrazone: acute and subchronic toxicity.
Nakornchai, S; Sookvanichsilp, N; Weerapradist, W, 1991
)
0.59
" The LD50 (lethal dose for 50% survival of group) of pyridoxalated polyethylene glycol (PEG) hemoglobin was greater than 200 ml/kg."( Efficacy and safety of hemoglobin-polyethylene glycol conjugate (pyridoxalated polyethylene glycol hemoglobin) as an oxygen-carrying resuscitation fluid.
Ikeda, K; Iwasaki, K; Iwashita, Y; Uematsu, T, 1986
)
0.76
" These findings suggest that UVA-induced vitamin B6 cytotoxicity is caused by toxic photoproducts resulting from irradiated vitamin B6."( Vitamin B6 phototoxicity induced by UVA radiation.
Kosaka, H; Maeda, T; Minami, H; Sato, K; Shiga, T; Taguchi, H; Yoshikawa, K, 2000
)
0.31
" K562 cells loaded with eicosapentaenoic acid, a fatty acid particularly susceptible to oxidation, were also more sensitive to the toxic effects of the Fe complexes, and toxicity was proportional to lipid peroxidation."( The role of oxidative stress in the toxicity of pyridoxal isonicotinoyl hydrazone (PIH) analogues.
Buss, JL; Neuzil, J; Ponka, P, 2002
)
0.57
" In contrast, PIH was inactive, while SIH was equally toxic toward control and EPA-loaded cells, without causing lipid peroxidation, indicating a much smaller contribution of oxidative stress to the mechanism of toxicity of these analogs."( Oxidative stress mediates toxicity of pyridoxal isonicotinoyl hydrazone analogs.
Buss, JL; Neuzil, J; Ponka, P, 2004
)
0.59
"Iron (Fe) chelation therapy was initially designed to alleviate the toxic effects of excess Fe evident in Fe-overload diseases."( Future of toxicology--iron chelators and differing modes of action and toxicity: the changing face of iron chelation therapy.
Kalinowski, DS; Richardson, DR, 2007
)
0.34
" No serious adverse effects occurred."( Efficacy and safety of pyridoxal in West syndrome: A retrospective study.
Daida, A; Hamano, SI; Hirata, Y; Ikemoto, S; Koichihara, R; Kubota, J; Matsuura, R, 2019
)
0.82

Pharmacokinetics

ExcerptReferenceRelevance
" Plasma clearance and volume of distribution of PLP decreased significantly after supplementation, but half-life t 1/2 did not change."( Relationship between body store of vitamin B6 and plasma pyridoxal-P clearance: metabolic balance studies in humans.
Aronoff, GR; Li, TK; Lui, A; Lumeng, L, 1985
)
0.51
" This method was successfully applied to the analysis of the samples obtained from a pilot pharmacokinetic experiment, in which the chelator was administered intravenously to rabbits."( HPLC determination of a novel aroylhydrazone iron chelator (o-108) in rabbit plasma and its application to a pilot pharmacokinetic study.
Gersl, V; Klimes, J; Kovaríková, P; Ponka, P; Popelová, O; Sterba, M, 2006
)
0.33
"The pharmacokinetic profile of Diclectin well explains its documented delayed efficacy."( Pharmacokinetic comparison of a delayed-release combination of doxylamine succinate and pyridoxine hydrocholoride (Diclectin) and oral solutions of these drugs in healthy women of childbearing age.
Koren, G; Nulman, I, 2009
)
0.35

Bioavailability

ExcerptReferenceRelevance
"Intraluminal perfusion of human jejunum has not been previously reported to demonstrate differences in bioavailability of vitamins from a food product."( Comparative human intestinal bioavailability of vitamin B-6 from a synthetic and a natural source.
Cerda, JJ; Lane, H; Nelson, EW, 1976
)
0.26
"An HPLC method for determining total pyridoxal from plasma was developed for a relative bioavailability comparison of two oral vitamin B6 (pyridoxine HCl) preparations."( Determination of total pyridoxal in human plasma following oral administration of vitamin B6 by high-performance liquid chromatography with post-column derivatization.
Mascher, H, 1993
)
0.87
"Diclectin exhibited similar oral bioavailability to those of the oral solutions."( Pharmacokinetic comparison of a delayed-release combination of doxylamine succinate and pyridoxine hydrocholoride (Diclectin) and oral solutions of these drugs in healthy women of childbearing age.
Koren, G; Nulman, I, 2009
)
0.35
" Collectively, these findings examining the mechanism of Dp44mT uptake and its distribution and excretion have clinical implications for its bioavailability and uptake in vivo."( Cellular uptake of the antitumor agent Dp44mT occurs via a carrier/receptor-mediated mechanism.
Kalinowski, DS; Menezes, SV; Merlot, AM; Pantarat, N; Richardson, DR; Sahni, S, 2013
)
0.39
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

ExcerptRelevanceReference
" brevis responded equally to all three free forms of vitamin B-6 at a dosage range of 2--10 ng molar equivalent of pyridoxine."( Growth response of the yeasts Saccharomyces uvarum and Kloeckera brevis to the free biologically active forms of vitamin B-6.
Guilarte, TR; McIntyre, PA; Tsan, MF, 1980
)
0.26
" A dose-response assay indicated that purified axolotl Tf stimulates growth of cultured blastemal cells at concentrations as low as 100 ng/mL."( Transferrin is necessary and sufficient for the neural effect on growth in amphibian limb regeneration blastemas.
Connell, E; Hsu, C; Mescher, AL; Overton, B; Patel, C, 1997
)
0.3
"Micro-thermal analysis (microTA) by scanning thermal microscopy is being used increasingly for the analysis of pharmaceutical dosage forms."( Differential scanning calorimetry and scanning thermal microscopy analysis of pharmaceutical materials.
Allen, S; Bond, L; Davies, MC; Roberts, CJ; Shivji, AP; Tendler, SJ; Williams, PM; Zhang, J, 2002
)
0.31
" We have generated a temperature-sensitive but stable version of the Gcs1 protein that is impaired only for trans-Golgi transport and find that deleterious effects of this enfeebled Gcs1-4 mutant protein are relieved by increased gene dosage of the gcs1-4 mutant gene itself or by the SFH2 gene (also called CSR1), encoding a phosphatidylinositol transfer protein (PITP)."( Membrane metabolism mediated by Sec14 family members influences Arf GTPase activating protein activity for transport from the trans-Golgi.
Fairn, GD; Johnston, GC; McMaster, CR; Poon, PP; Shmulevitz, M; Singer, RA; Wong, TA, 2005
)
0.33
" The dose-response relation between CRP and B-6 vitamers at day 28 was nonlinear, with an increased steepness of slope at CRP >7 mg/L."( Association of plasma B-6 vitamers with systemic markers of inflammation before and after pyridoxine treatment in patients with stable angina pectoris.
Midttun, Ø; Nygård, O; Pedersen, ER; Ueland, PM; Ulvik, A, 2012
)
0.38
" Study participants with elevated PAr experienced a higher risk of incident stroke in an essentially linear dose-response fashion."( The PAr index, an indicator reflecting altered vitamin B-6 homeostasis, is associated with long-term risk of stroke in the general population: the Hordaland Health Study (HUSK).
Meyer, K; Midttun, Ø; Nygård, O; Tell, GS; Ueland, PM; Ulvik, A; Vollset, SE; Zuo, H, 2018
)
0.48
" Notably, there is a lack of studies on the general population and studies of the dose-response relationship."( Association of Pyridoxal 5'-Phosphate with Sleep-Related Problems in a General Population.
Ge, L; Kang, X; Luo, J; Zhang, D; Zhang, L, 2022
)
1.07
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (5)

RoleDescription
cofactorAn organic molecule or ion (usually a metal ion) that is required by an enzyme for its activity. It may be attached either loosely (coenzyme) or tightly (prosthetic group).
human metaboliteAny mammalian metabolite produced during a metabolic reaction in humans (Homo sapiens).
Saccharomyces cerevisiae metaboliteAny fungal metabolite produced during a metabolic reaction in Baker's yeast (Saccharomyces cerevisiae).
Escherichia coli metaboliteAny bacterial metabolite produced during a metabolic reaction in Escherichia coli.
mouse metaboliteAny mammalian metabolite produced during a metabolic reaction in a mouse (Mus musculus).
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (5)

ClassDescription
vitamin B6Any member of the group of pyridines that exhibit biological activity against vitamin B6 deficiency. Vitamin B6 deficiency is associated with microcytic anemia, electroencephalographic abnormalities, dermatitis with cheilosis (scaling on the lips and cracks at the corners of the mouth) and glossitis (swollen tongue), depression and confusion, and weakened immune function. Vitamin B6 consists of the vitamers pyridoxine, pyridoxal, and pyridoxamine and their respective 5'-phosphate esters (and includes their corresponding ionized and salt forms).
pyridinecarbaldehyde
methylpyridinesAny member of the class of pyridines that carries at least one methyl substituent.
monohydroxypyridineA hydroxypyridine carrying a single hydroxy substituent.
hydroxymethylpyridineAny member of the class of pyridines carrying a hydroxymethyl substituent at unspecified position.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (22)

PathwayProteinsCompounds
Metabolism14961108
Metabolism of vitamins and cofactors146155
Metabolism of water-soluble vitamins and cofactors102114
Vitamin B6 activation to pyridoxal phosphate318
Vitamin B6 Metabolism515
Hypophosphatasia515
Vitamin B6228
pyridoxal 5'-phosphate salvage II (plants)319
pyridoxal 5'-phosphate salvage I114
Vitamin B6 metabolism ( Vitamin B6 metabolism )417
pyridoxal 5'-phosphate salvage213
superpathway of b heme biosynthesis from glycine1046
vitamin B6 degradation1029
4-amino-2-methyl-5-diphosphomethylpyrimidine biosynthesis (yeast)729
superpathway of bacteriochlorophyll a biosynthesis2270
pyridoxal 5'-phosphate salvage I519
superpathway of pyridoxal 5'-phosphate biosynthesis and salvage937
tetrapyrrole biosynthesis II (from glycine)730
superpathway of thiamin diphosphate biosynthesis III (eukaryotes)2541
pyridoxal 5'-phosphate salvage pathway414
4-amino-2-methyl-5-phosphomethylpyrimidine biosynthesis1229
pyridoxamine anabolism08
Superpathway of pyridoxal 5'-phosphate biosynthesis and salvage014
Vitamin B6-dependent and responsive disorders219
Pyridoxal 5'-phosphate salvage pathway112
Pyridoxamine anabolism17

Protein Targets (15)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, MAJOR APURINIC/APYRIMIDINIC ENDONUCLEASEHomo sapiens (human)Potency89.12510.003245.467312,589.2998AID2517
Chain A, 2-oxoglutarate OxygenaseHomo sapiens (human)Potency31.62280.177814.390939.8107AID2147
phosphopantetheinyl transferaseBacillus subtilisPotency79.43280.141337.9142100.0000AID1490
aldehyde dehydrogenase 1 family, member A1Homo sapiens (human)Potency31.62280.011212.4002100.0000AID1030
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency15.48710.01237.983543.2770AID1645841
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency19.95260.035520.977089.1251AID504332
15-hydroxyprostaglandin dehydrogenase [NAD(+)] isoform 1Homo sapiens (human)Potency14.12540.001815.663839.8107AID894
heat shock protein beta-1Homo sapiens (human)Potency14.95890.042027.378961.6448AID743210
nuclear factor erythroid 2-related factor 2 isoform 1Homo sapiens (human)Potency18.83220.000627.21521,122.0200AID743202
gemininHomo sapiens (human)Potency13.33590.004611.374133.4983AID624297
DNA polymerase kappa isoform 1Homo sapiens (human)Potency23.77810.031622.3146100.0000AID588579
histone acetyltransferase KAT2A isoform 1Homo sapiens (human)Potency31.62280.251215.843239.8107AID504327
lamin isoform A-delta10Homo sapiens (human)Potency31.62280.891312.067628.1838AID1487
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Aldehyde oxidaseHomo sapiens (human)Ki30.00000.00090.46072.3000AID34176
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Pyridoxal kinaseHomo sapiens (human)Km59.00005.00007.45009.9000AID464423
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (5)

Processvia Protein(s)Taxonomy
pyridoxal 5'-phosphate salvagePyridoxal kinaseHomo sapiens (human)
pyridoxal metabolic processPyridoxal kinaseHomo sapiens (human)
pyridoxamine metabolic processPyridoxal kinaseHomo sapiens (human)
lipid metabolic processAldehyde oxidaseHomo sapiens (human)
xenobiotic metabolic processAldehyde oxidaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (17)

Processvia Protein(s)Taxonomy
magnesium ion bindingPyridoxal kinaseHomo sapiens (human)
ATP bindingPyridoxal kinaseHomo sapiens (human)
zinc ion bindingPyridoxal kinaseHomo sapiens (human)
pyridoxal kinase activityPyridoxal kinaseHomo sapiens (human)
pyridoxal phosphate bindingPyridoxal kinaseHomo sapiens (human)
potassium ion bindingPyridoxal kinaseHomo sapiens (human)
sodium ion bindingPyridoxal kinaseHomo sapiens (human)
lithium ion bindingPyridoxal kinaseHomo sapiens (human)
protein homodimerization activityPyridoxal kinaseHomo sapiens (human)
aldehyde oxidase activityAldehyde oxidaseHomo sapiens (human)
iron ion bindingAldehyde oxidaseHomo sapiens (human)
identical protein bindingAldehyde oxidaseHomo sapiens (human)
protein homodimerization activityAldehyde oxidaseHomo sapiens (human)
molybdopterin cofactor bindingAldehyde oxidaseHomo sapiens (human)
flavin adenine dinucleotide bindingAldehyde oxidaseHomo sapiens (human)
NAD bindingAldehyde oxidaseHomo sapiens (human)
2 iron, 2 sulfur cluster bindingAldehyde oxidaseHomo sapiens (human)
FAD bindingAldehyde oxidaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (7)

Processvia Protein(s)Taxonomy
extracellular regionPyridoxal kinaseHomo sapiens (human)
nucleusPyridoxal kinaseHomo sapiens (human)
nucleoplasmPyridoxal kinaseHomo sapiens (human)
cytosolPyridoxal kinaseHomo sapiens (human)
secretory granule lumenPyridoxal kinaseHomo sapiens (human)
specific granule lumenPyridoxal kinaseHomo sapiens (human)
extracellular exosomePyridoxal kinaseHomo sapiens (human)
cytosolPyridoxal kinaseHomo sapiens (human)
cytosolAldehyde oxidaseHomo sapiens (human)
extracellular exosomeAldehyde oxidaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (49)

Assay IDTitleYearJournalArticle
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID626545Competitive inhibition of Cu2-amyloid beta (1 to 20) complex-induced DTBC oxidation by spectrophotometry2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Vitamin B6s inhibit oxidative stress caused by Alzheimer's disease-related Cu(II)-β-amyloid complexes-cooperative action of phospho-moiety.
AID1755451Drug excretion in human urine assessed as maximum urinary excretion of pyridoxic-acid at 3.36 mg, po2020Journal of medicinal chemistry, 12-10, Volume: 63, Issue:23
Curse or Cure? A Perspective on the Developability of Aldehydes as Active Pharmaceutical Ingredients.
AID464424Lipophilicity, log P of the compound2010Journal of natural products, Jan, Volume: 73, Issue:1
Ginkgo biloba and ginkgotoxin.
AID1755449Cmax in human at 3.36 mg, po measured for 7 days2020Journal of medicinal chemistry, 12-10, Volume: 63, Issue:23
Curse or Cure? A Perspective on the Developability of Aldehydes as Active Pharmaceutical Ingredients.
AID626546Competitive inhibition of Cu2-amyloid beta (1 to 20) complex-induced THB oxidation by spectrophotometry2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Vitamin B6s inhibit oxidative stress caused by Alzheimer's disease-related Cu(II)-β-amyloid complexes-cooperative action of phospho-moiety.
AID626547Competitive inhibition of Cu2-amyloid beta (1 to 16) complex-induced DTBC oxidation by spectrophotometry2011Bioorganic & medicinal chemistry letters, Nov-01, Volume: 21, Issue:21
Vitamin B6s inhibit oxidative stress caused by Alzheimer's disease-related Cu(II)-β-amyloid complexes-cooperative action of phospho-moiety.
AID1755450Drug excretion in human assessed as time of maximum urinary excretion of pyridoxic-acid at 3.36 mg, po2020Journal of medicinal chemistry, 12-10, Volume: 63, Issue:23
Curse or Cure? A Perspective on the Developability of Aldehydes as Active Pharmaceutical Ingredients.
AID1755446Drug metabolism in human assessed as pyridoxal-5-phosphate Cmax at 3.36 mg, po2020Journal of medicinal chemistry, 12-10, Volume: 63, Issue:23
Curse or Cure? A Perspective on the Developability of Aldehydes as Active Pharmaceutical Ingredients.
AID112595Percent increase in life span of mice bearing L1210 ascites cells compared to control (in vivo)1980Journal of medicinal chemistry, Mar, Volume: 23, Issue:3
Cyclophosphamide potentiation and aldehyde oxidase inhibition by phosphorylated aldehydes and acetals.
AID34176Tested for its ability to inhibit rabbit liver aldehyde oxidase catalyzed oxidation of N-methyl-nicotinamide (NMN)1980Journal of medicinal chemistry, Mar, Volume: 23, Issue:3
Cyclophosphamide potentiation and aldehyde oxidase inhibition by phosphorylated aldehydes and acetals.
AID124392Percent animals surviving 50 days from day 1 (in vivo)1980Journal of medicinal chemistry, Mar, Volume: 23, Issue:3
Cyclophosphamide potentiation and aldehyde oxidase inhibition by phosphorylated aldehydes and acetals.
AID1755452Drug excretion in human urine at 3.36 mg, po measured within 24 hrs2020Journal of medicinal chemistry, 12-10, Volume: 63, Issue:23
Curse or Cure? A Perspective on the Developability of Aldehydes as Active Pharmaceutical Ingredients.
AID1755448Tmax in human at 3.36 mg, po2020Journal of medicinal chemistry, 12-10, Volume: 63, Issue:23
Curse or Cure? A Perspective on the Developability of Aldehydes as Active Pharmaceutical Ingredients.
AID1755447Drug metabolism in human assessed as pyridoxal-5-phosphate Tmax at 3.36 mg, po2020Journal of medicinal chemistry, 12-10, Volume: 63, Issue:23
Curse or Cure? A Perspective on the Developability of Aldehydes as Active Pharmaceutical Ingredients.
AID464423Activity at human PKH kinase expressed in Escherichia coli by affinity chromatography2010Journal of natural products, Jan, Volume: 73, Issue:1
Ginkgo biloba and ginkgotoxin.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,098)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990641 (58.38)18.7374
1990's145 (13.21)18.2507
2000's119 (10.84)29.6817
2010's122 (11.11)24.3611
2020's71 (6.47)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 69.04

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index69.04 (24.57)
Research Supply Index7.05 (2.92)
Research Growth Index4.51 (4.65)
Search Engine Demand Index172.58 (26.88)
Search Engine Supply Index2.83 (0.95)

This Compound (69.04)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials14 (1.23%)5.53%
Reviews53 (4.65%)6.00%
Case Studies43 (3.78%)4.05%
Observational0 (0.00%)0.25%
Other1,029 (90.34%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (58)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
PILOTSTUDIE ZUR PYRIDOXALPHOSPHATTHERAPIE BEI PATIENTEN MIT PRIMÄRER HYPEROXALURIE TYP I (PHOX-B6-PILOT) Pilot Trial on Treatment of Patients With Primary Hyperoxaluria Type I With Pyridoxal-phosphate [NCT01281878]Phase 212 participants (Actual)Interventional2010-12-31Completed
Renal Protective Effect and Clinical Analysis of Vitamin B6 in Patients With Sepsis [NCT06008223]128 participants (Actual)Interventional2021-11-01Completed
Folic Acid and B Vitamins for Secondary Prevention of Stroke : A Double-blinded Randomized Controlled Trial [NCT01317849]0 participants (Actual)Interventional2011-07-31Withdrawn(stopped due to financial assistance financial assistance financial assistance financial assistance financial assistance without financial assistance)
An Exploratory Single Blind Study of Ergoloid Mesylates, 5-Hydroxytryptophan, and the Combination in Adult Males With Fragile X Syndrome [NCT05030129]Phase 215 participants (Actual)Interventional2021-10-07Completed
StAT-TB (Statin Adjunctive Therapy for TB): A Phase 2b Dose-finding Study of Pravastatin in Adults With Tuberculosis [NCT03882177]Phase 216 participants (Actual)Interventional2020-02-21Completed
Effects of Vitamin Supplementation and Strength Training in Parkinson's Disease [NCT01238926]40 participants (Anticipated)Interventional2008-05-31Active, not recruiting
Vitamin B6 and Magnesium on Neurobehavioral Status of Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study [NCT03963479]Phase 250 participants (Anticipated)Interventional2019-01-01Recruiting
Study of Pyridoxal 5'-Phosphate for the Treatment of Patients With PNPO Deficiency [NCT04706013]Phase 315 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Pyridoxine, P2 Receptor Antagonism, and ATP-mediated Vasodilation in Young Adults [NCT03738943]Early Phase 19 participants (Actual)Interventional2019-02-07Completed
A Pilot Study of the Preoperative Misoprostol in Reducing Operative Blood Loss During Hysterectomy [NCT01199159]77 participants (Actual)Interventional2007-01-31Completed
Vitamin B6 Concentration and Treatment in Nausea and Vomiting of Pregnancy [NCT00763633]Phase 4150 participants (Anticipated)Interventional2008-01-31Recruiting
A Randomized Trial to Determine if Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Treated With Capecitabine Chemotherapy [NCT00767689]6 participants (Actual)Interventional2006-03-21Terminated(stopped due to incomplete enrollment)
One-month Latent Tuberculosis Treatment for Renal Transplant Candidates [NCT05411744]Phase 425 participants (Anticipated)Interventional2022-07-01Recruiting
A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients. [NCT00659269]Phase 3319 participants (Actual)Interventional2006-07-31Completed
An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease [NCT00853879]150 participants (Actual)Interventional2006-12-31Terminated
A Randomized, Double-Blind, Placebo-Controlled, Comparative Study to Evaluate the Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia in Patients With Schizophrenia and Schizoaffective Disorders [NCT00917293]Phase 253 participants (Actual)Interventional2009-05-31Terminated(stopped due to modified formulation under investigation)
Uterine Fibroids Are a Very Common Finding in Women of Reproductive Age. Ready Safety Study Extracts of Plants Pregnenolone & Pyridoxal Phosphate for Treating Uterine Fibroids in Women of Reproductive Age and Women Pregnancy. [NCT04762316]66 participants (Actual)Interventional2019-01-01Completed
Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids: a Randomized Controlled Trial [NCT05409872]108 participants (Anticipated)Interventional2022-09-15Recruiting
Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx® [NCT00933998]20 participants (Actual)Interventional2006-06-30Completed
Evaluation of the Role of Pyridoxine Adjuvant Therapy on the Blood Glucose Level in Type 2 Diabetic Patients [NCT05918068]108 participants (Actual)Interventional2022-11-01Completed
Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder [NCT05649293]94 participants (Anticipated)Observational2023-04-01Not yet recruiting
The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder: A Pilot Study [NCT00704990]Phase 2/Phase 328 participants (Actual)Interventional2008-09-30Completed
Vitamin B6 Supplementation and Mood States in College Women Taking Oral Contraceptives [NCT04070391]8 participants (Actual)Interventional2019-01-01Completed
Efficacy of the Association of Hyaluronic Acid With High Molecular Weight, α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion in Patients at Risk [NCT05449171]100 participants (Anticipated)Interventional2022-09-01Recruiting
A Double Blind Placebo Control Randomised Trial to Test the Effectiveness of Vitamin B6 in Hand Foot Syndrome [NCT02625415]54 participants (Actual)Interventional2016-07-31Completed
Protocol Comparing a Nutraceutical Formulation Consisting of Omega-3 Fatty Acids, Vitamin D, and Vitamins B6 Plus B12 Versus No Treatment in the Prevention or Reduction of Chemotherapy Induced Peripheral Neuropathy (CIPN) in Patients Treated With Docetaxe [NCT02795572]Phase 213 participants (Actual)Interventional2017-06-27Terminated(stopped due to Retirement of the Principal Investigator)
Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application [NCT02758990]16 participants (Actual)Interventional2016-03-31Terminated(stopped due to Recruiting and financial constraints)
Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals With Latent Tuberculosis Infection [NCT01404312]Phase 33,000 participants (Actual)Interventional2012-05-23Completed
Chelation Therapy of Iron Overload With Oral Pyridoxal Isonicotinoyl Hydrazone [NCT00000588]Phase 2120 participants (Actual)Interventional1989-06-05Completed
MEND-CABG II: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG Surgery [NCT00402506]Phase 33,000 participants (Anticipated)Interventional2006-11-30Completed
[NCT01964001]Phase 2/Phase 371 participants (Actual)Interventional2014-01-31Completed
Vitamin B6 Effects on One-Carbon Metabolism [NCT01128244]Phase 2/Phase 313 participants (Actual)Interventional2010-04-30Completed
A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study [NCT04311502]Phase 2104 participants (Actual)Interventional2021-06-16Active, not recruiting
The Early Bactericidal Activity of High-Dose or Standard-Dose Isoniazid Among Adult Participants With Isoniazid-Resistant or Drug-Sensitive Tuberculosis [NCT01936831]Phase 2282 participants (Actual)Interventional2014-08-13Completed
[NCT01426490]Phase 2/Phase 3300 participants (Anticipated)Interventional2011-08-31Recruiting
[NCT00706888]64 participants (Anticipated)InterventionalCompleted
Oral Misoprostol Before Endometrial Biopsy [NCT00200226]Phase 372 participants (Actual)Interventional2003-02-28Completed
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Cardiovascular and Cerebrovascular Effects of MC-1 in Patients Undergoing High-Risk Coronary Artery Bypass Graft (CABG) Surgery [NCT00157716]Phase 2900 participants Interventional2004-04-30Completed
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB) [NCT03568383]Phase 35,610 participants (Anticipated)Interventional2019-06-03Recruiting
HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study) [NCT00106886]Phase 45,000 participants Interventional1999-12-31Active, not recruiting
B-Vitamin Atherosclerosis Intervention Trial (BVAIT) [NCT00114400]Phase 2/Phase 3506 participants Interventional2000-11-30Completed
Evaluation of the Effects of MC-1 Alone and in Combination With an ACE Inhibitor on Ambulatory Blood Pressure and Metabolic Function in Hypertensive Patients With Type 2 Diabetes Mellitus [NCT00157729]Phase 2160 participants Interventional2004-08-31Completed
High Dose Supplements to Reduce Homocysteine and Slow the Rate of Cognitive Decline in Alzheimer's Disease (Vitamins to Slow Alzheimer's - VITAL) [NCT00056225]Phase 3340 participants (Actual)Interventional2003-01-31Completed
Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI) [NCT06020300]Phase 464 participants (Anticipated)Interventional2023-07-28Recruiting
Randomized Trial of Homocysteine-lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. The Norwegian Vitamin Trial (NORVIT) [NCT00266487]3,750 participants Interventional1998-12-31Completed
Implementation for Tuberculosis Preventive Therapy Among Latent Tuberculosis Infection in HIV-infected Individuals Using Novel Regimen of Isoniazid/Rifapentine Daily (4 Weeks) Compared to Isoniazid/Rifapentine Weekly (12 Weeks) [NCT03785106]Phase 32,500 participants (Anticipated)Interventional2019-08-15Recruiting
Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding (AUB) Using Sublingual Misoprostol 200 Mcg: A Randomized, Double Blind, Placebo-controlled Trial [NCT01762319]52 participants (Anticipated)Interventional2012-11-30Recruiting
A Phase I/II Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-1-infected and HIV-1-uninfected Pregnant and Postpartum Women With Latent Tuberculosis Infection [NCT02651259]Phase 1/Phase 250 participants (Actual)Interventional2017-03-13Completed
Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Neuroprotective Effect of Vitamin B6 and Vitamin B12 Against Vincristine Induced Neurotoxicity in Acute Lymphoblastic Leukaemia Patients [NCT03593304]Phase 2/Phase 340 participants (Actual)Interventional2018-03-29Completed
Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS) [NCT00000541]Phase 20 participants Interventional1993-05-31Completed
A Randomised Double Blind Study of the Effects of Homocysteine Lowering Therapy on Mortality and Cardiac Events in Patients Undergoing Coronary Angiography [NCT00354081]Phase 33,096 participants (Actual)Interventional1999-04-30Completed
Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder [NCT05813366]39 participants (Anticipated)Interventional2023-04-25Not yet recruiting
The Use of Vitamin D in Combination With Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in the Treatment of Women With Uterine Fibroid [NCT05448365]Phase 360 participants (Anticipated)Interventional2022-07-01Recruiting
The Neurobehavioral and Biochemical Effects of High Dose of Vitamin B6 With Magnesium in Children With Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study [NCT04509401]66 participants (Actual)Interventional2020-01-11Completed
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of Magnesium Vitamin B6 in Combination With Treatment as Usual in First Episode of Bipolar I Disorder [NCT05837104]Phase 240 participants (Anticipated)Interventional2023-12-13Recruiting
Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals [NCT04272242]Phase 272 participants (Anticipated)Interventional2020-08-01Suspended(stopped due to Following completion of Arm 1, A5372 is currently Temporarily Closed. Timeline for opening of Arm 2 is not available.)
The Effects of Vitamin B-6 and Glutathione on Inflammatory Responses, Homocysteine Metabolism, Oxidative Stress and Antioxidant Capacities in Patients With Liver Cirrhosis or Hepatocellular Carcinoma [NCT02321579]25 participants (Anticipated)Interventional2014-12-31Recruiting
A Pilot Study of the Effects of Vitamin B6 on Hot Flash Symptoms in Prostate Cancer Patients [NCT03580499]40 participants (Actual)Interventional2018-09-13Active, not recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00659269 (4) [back to overview]Change in Neurotoxicity Assessment Between Cycle 4 and Baseline
NCT00659269 (4) [back to overview]Neurotoxicity Assessment at Baseline
NCT00659269 (4) [back to overview]Neurotoxicity Assessment at Cycle 2
NCT00659269 (4) [back to overview]Neurotoxicity Assessment at Cycle 4
NCT01128244 (5) [back to overview]Fasting Plasma Cystathionine Concentration
NCT01128244 (5) [back to overview]Plasma 3-hydroxykynurenine Concentration
NCT01128244 (5) [back to overview]Total Remethylation of Homocysteine
NCT01128244 (5) [back to overview]Fasting Plasma Pyridoxal Phosphate Concentration
NCT01128244 (5) [back to overview]Flux of Homocysteine Remethylation From Serine-derived Carbon
NCT01404312 (6) [back to overview]Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause
NCT01404312 (6) [back to overview]Cumulative Incidence of Death Due to a Non-TB Event
NCT01404312 (6) [back to overview]Cumulative Incidence of Death From Any Cause
NCT01404312 (6) [back to overview]Efavirenz (EFV) Plasma Concentrations in Arm A
NCT01404312 (6) [back to overview]Nevirapine (NVP) Plasma Concentrations in Arm A
NCT01404312 (6) [back to overview]Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis
NCT01936831 (10) [back to overview]Daily Change in TTP Measured by Early- (EBA0-2) and Late-phase (EBA2-7) Individual-based Parameter Estimates From Nonlinear Models
NCT01936831 (10) [back to overview]INH Minimum Inhibitory Concentration (MIC) Against M. Tuberculosis Isolates
NCT01936831 (10) [back to overview]Daily Change in log10 Colony-forming Unit (CFU)
NCT01936831 (10) [back to overview]Daily Change in Time to Positivity (TTP)
NCT01936831 (10) [back to overview]INH PK Parameter Area Under the Concentration Time Curve (AUC 0-24 Hours)
NCT01936831 (10) [back to overview]INH PK Parameter Maximum Plasma Concentration (Cmax)
NCT01936831 (10) [back to overview]INH PK Parameter Minimum Plasma Concentration (Cmin)
NCT01936831 (10) [back to overview]Number of Participants With Grade 2 or Higher Drug-related Adverse Clinical or Laboratory Events
NCT01936831 (10) [back to overview]Proportions of Participants Estimated to Have a Drop in log10 CFU/mL at or Above 0.65 log10 CFU/mL.
NCT01936831 (10) [back to overview]Daily Change in log10 CFU Measured by Early- (EBA0-2) and Late-phase (EBA2-7) Individual-based Parameter Estimates From Nonlinear Models
NCT02651259 (24) [back to overview]Absorption (ka) of INH
NCT02651259 (24) [back to overview]Absorption Rate Constant (ka) for Rifapentine (RPT)
NCT02651259 (24) [back to overview]Clearance Relative to Bioavailability (CL/F) for Rifapentine (RPT)
NCT02651259 (24) [back to overview]Clearance Relative to Bioavailability (CL/F) for Rifapentine (RPT) for Intensive and Sparse PK
NCT02651259 (24) [back to overview]Clearance Relative to Bioavailability (CLmet/F) for Desacetyl Rifapentine (Des-RPT)
NCT02651259 (24) [back to overview]Cord Blood Concentrations of Desacetyl Rifapentine (Des-RPT) Among Infants
NCT02651259 (24) [back to overview]Cord Blood Concentrations of Rifapentine (RPT) Among Infants
NCT02651259 (24) [back to overview]Incidence of Related Serious Adverse Events (SAEs) in Pregnant and Postpartum Women Taking Once-weekly RPT + INH
NCT02651259 (24) [back to overview]Number of Infants With Active TB up to 24 Weeks of Life
NCT02651259 (24) [back to overview]Number of Mothers With Active TB up to 24 Weeks Postpartum
NCT02651259 (24) [back to overview]Number of Participants With Discontinuation of Study Drug Due to Intolerance (Tolerability of Study Drug Regimen - i.e., RPT, INH, and Pyridoxine)
NCT02651259 (24) [back to overview]Percentage of Participants With All AEs Leading to Permanent Discontinuation of Study Drug Regimen (i.e., RPT, INH, and Pyridoxine)
NCT02651259 (24) [back to overview]Percentage of Participants With All Grade 3 and 4 AEs
NCT02651259 (24) [back to overview]Percentage of Participants With All Serious AEs
NCT02651259 (24) [back to overview]Percentage of Participants With Grade 2 Adverse Events (AEs) Judged to be Related to Study Drug Regimen
NCT02651259 (24) [back to overview]Percentage of Participants With Related Serious Adverse Events (AEs) in Infants Born to Women Taking Once-weekly RPT + INH
NCT02651259 (24) [back to overview]Plasma Concentrations of Desacetyl Rifapentine (Des-RPT) Among Infants
NCT02651259 (24) [back to overview]Plasma Concentrations of Rifapentine (RPT) Among Infants
NCT02651259 (24) [back to overview]Volume of Distribution of INH
NCT02651259 (24) [back to overview]Volume of Distribution Relative to Bioavailability (Vc/F) for Rifapentine (RPT)
NCT02651259 (24) [back to overview]Area Under the Curve From 0 to 24 Hours (AUC0-24) for RPT and Area Under the Curve From 0 to 24 Hours (AUC0-24) for Des-RPT Pregnant Women in 2nd and 3rd Trimester
NCT02651259 (24) [back to overview]Clearance (CL/F) of INH
NCT02651259 (24) [back to overview]Maximum Concentration (Cmax) for RPT Maximum Concentration (Cmax) for Des-RPT Pregnant Women in 2nd and 3rd Trimester
NCT02651259 (24) [back to overview]Maximum Concentration (Cmin) for RPT and Maximum Concentration (Cmin) for Des-RPT Pregnant Women in 2nd and 3rd Trimester
NCT03882177 (2) [back to overview]Number of Participants Who Permanently Discontinue Assigned Study Regimen for Any Reason
NCT03882177 (2) [back to overview]Frequency of Grade 3 or Higher Adverse Events

Change in Neurotoxicity Assessment Between Cycle 4 and Baseline

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients. (NCT00659269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm7.0
Taxane Group: MV + Vitamin B12 + Vitamin B67.2
Heavy Metals Group: Multivitamin (MV) Arm3.9
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm4.7
Vinca Alkaloids Group: Multivitamin (MV) Arm11.8
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm7

[back to top]

Neurotoxicity Assessment at Baseline

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported. (NCT00659269)
Timeframe: At study start; prior to treatment (week 0)

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm8.5
Taxane Group: MV + Vitamin B12 + Vitamin B67.3
Heavy Metals Group: Multivitamin (MV) Arm5.23
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm4.58
Vinca Alkaloids Group: Multivitamin (MV) Arm6.80
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm2.08

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Neurotoxicity Assessment at Cycle 2

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported. (NCT00659269)
Timeframe: 2 weeks

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm13.0
Taxane Group: MV + Vitamin B12 + Vitamin B612.0
Heavy Metals Group: Multivitamin (MV) Arm9.7
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm8.4
Vinca Alkaloids Group: Multivitamin (MV) Arm14.56
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm5.6

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Neurotoxicity Assessment at Cycle 4

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported. (NCT00659269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm14.5
Multivitamin + Vitamin B12 + Vitamin B614.5
Heavy Metals Group: Multivitamin (MV) Arm8.71
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm7.05
Vinca Alkaloids Group: Multivitamin (MV) Arm17.5
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm9.22

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Fasting Plasma Cystathionine Concentration

For all subjects, the concentration of plasma cystathionine in fasting blood samples taken before and after the supplementation period will provide a functional measure of vitamin B6 nutritional status. (NCT01128244)
Timeframe: Fasting blood samples will be taken at baseline and after 28 days of vitamin B6 supplementation.

Interventionmicromol/L (Mean)
Baseline prior to vitamin supplementationAfter 28-days of vitamin supplementation
Plasma Cystathionine Concentration0.140.13

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Plasma 3-hydroxykynurenine Concentration

For all subjects, analysis of blood samples before and after vitamin B6 supplementation will allow evaluation of discriminating biomarkers using targeted metabolite profile analysis of one-carbon metabolism and tryptophan catabolism constituents. Also, we will conduct exploratory evaluation and potential identification of new biomarkers using metabolomics analysis on subjects before and after vitamin B6 supplementation. (NCT01128244)
Timeframe: April, 2010 - June, 2014

Interventionmicrol/L (Mean)
Baseline prior to vitamin supplementationAfter 28-days of vitamin supplementation
Secondary Analysis: Plasma 3-hydroxykynurenine Concentration25.927.3

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Total Remethylation of Homocysteine

Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of total remethylation of homocysteine before and after vitamin B6 supplementation. (NCT01128244)
Timeframe: Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 days

Interventionmicromol/(kg x hr) (Mean)
Baseline prior to vitamin supplementationAfter 28-days of vitamin supplementation
Total Homocysteine Remethylation Flux6.075.63

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Fasting Plasma Pyridoxal Phosphate Concentration

For all subjects, the concentration of plasma pyridoxal phosphate in fasting blood samples taken before and after the supplementation period will provide a direct measure of vitamin B6 nutritional status. (NCT01128244)
Timeframe: Fasting blood samples will be taken at baseline and after 28 days of vitamin B6 supplementation.

Interventionnmol/L (Mean)
Baseline prior to vitamin supplementationAfter 28-days of vitamin supplementation
Plasma Pyridoxal Phosphate Concentration25.8143

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Flux of Homocysteine Remethylation From Serine-derived Carbon

Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of homocysteine remethylation from serine-derived carbon before and after vitamin B6 supplementation. These flux values may be slightly higher than flux of total homocysteine remethylation in Outcome Measure 1 because of the small contribution of methionine salvage to the flux measured in Outcome Measure 2. (NCT01128244)
Timeframe: Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 days

Interventionmicromol/(kg x hr) (Mean)
Baseline prior to vitamin supplementationAfter 28-days of vitamin supplementation
Homocysteine Remethylation Flux From Serine6.606.92

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Cumulative Incidence of Death Due to a Non-TB Event

Cumulative incidence function estimated nonparametrically, treating TB-related deaths as competing risks. (NCT01404312)
Timeframe: From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)

,
Interventionevents per 100 participants (Number)
Cumulative incidence by 1 year post-randomizationCumulative incidence by 2 years post-randomizationCumulative incidence by 3 years post-randomizationCumulative incidence by 4 years post-randomization
INH Regimen (Arm B)0.51.01.52.0
RPT Plus INH Regimen (Arm A)0.30.40.91.6

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Cumulative Incidence of Death From Any Cause

Data table estimates for percentage who died by each time point were estimated using Kaplan-Meier at 1, 2, 3, and 4 years post-entry. (NCT01404312)
Timeframe: From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)

,
Interventionevents per 100 participants (Number)
1 year post-entry2 years post-entry3 years post-entry4 years post-entry
INH Regimen (Arm B)0.631.151.622.29
RPT Plus INH Regimen (Arm A)0.350.491.052.00

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Efavirenz (EFV) Plasma Concentrations in Arm A

"Mean and standard deviation.~Week 16 samples have not yet been analyzed because the metabolite assay is being validated, and requires submission for approval by the Clinical Pharmacology Quality Assurance Program. Analysis of week 16 samples are anticipated to be available in September 2019." (NCT01404312)
Timeframe: Measured at Weeks 0, 2, 4, and 16

Interventionnanograms per mL (Mean)
Week 0Week 2Week 4
RPT Plus INH Regimen (Arm A)378738704082

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Nevirapine (NVP) Plasma Concentrations in Arm A

Mean and standard deviation (NCT01404312)
Timeframe: Measured at Weeks 0, 2, and 4

Interventionnanograms per mL (Mean)
Week0Week 2Week 4
RPT Plus INH Regimen (Arm A)757362345797

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Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis

Among MTB-diagnosed participants who underwent drug-susceptibility testing, the number who had any resistance to a particular drug. (NCT01404312)
Timeframe: After TB diagnosis

InterventionParticipants (Count of Participants)
Rifampin72268104Rifampin72268105Isoniazid72268104Isoniazid72268105Ethambutol72268104Ethambutol72268105Pyrazinamide72268104Pyrazinamide72268105
Developed ResistanceDid not Develop Resistance
RPT Plus INH Regimen (Arm A)1
INH Regimen (Arm B)1
RPT Plus INH Regimen (Arm A)14
INH Regimen (Arm B)11
RPT Plus INH Regimen (Arm A)2
RPT Plus INH Regimen (Arm A)12
RPT Plus INH Regimen (Arm A)0
RPT Plus INH Regimen (Arm A)7
INH Regimen (Arm B)7
INH Regimen (Arm B)0
RPT Plus INH Regimen (Arm A)6
INH Regimen (Arm B)6

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Daily Change in TTP Measured by Early- (EBA0-2) and Late-phase (EBA2-7) Individual-based Parameter Estimates From Nonlinear Models

The time to positivity (TTP) measures growth of mycobacterium tuberculosis using MGIT assay in hours. Higher values of daily change in TTP indicate greater decrease in bacterial burden over the time period and is therefore better. The mean log transformed TTP are estimated using all values by fitting a biphasic regression models for each participant. The daily change over the first two days of treatment is calculated as EBA0-2 (TTP)= [Day 2 TTP - baseline TTP]/2. The daily change from Day 2 to Day 7 is calculated as EBA2-7 (TTP)= [Day 7 TTP - Day 2 TTP]/5. Baseline is the average of pre-evaluation and entry visits. (NCT01936831)
Timeframe: At baseline, day 2, and day 7

,,,,,
Interventionhours per day (Mean)
EBA(0-2)EBA(2-7)
Group 1: 10mg Cohort11.035.45
Group 1: 15mg Cohort7.3512.01
Group 1: 5mg Cohort7.781.77
Group 2: 5mg Cohort22.395.09
Group 3: 15mg Cohort2.912.69
Group 3: 20mg Cohort-1.365.45

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INH Minimum Inhibitory Concentration (MIC) Against M. Tuberculosis Isolates

MIC are determined by phenotypic drug susceptibility testing (DST) based on spot sputum collected at Step 1 Day 0. For group 3 participants shown, MIC was tested using Thermofisher Sensititre MYCOTB plates. (NCT01936831)
Timeframe: Day 0

InterventionParticipants (Count of Participants)
0.03 μg/mL0.06 μg/mL0.12 μg/mL0.25 μg/mL0.5 μg/mL1 μg/mL2 μg/mL4 μg/mL>4 μg/mL
Step 1 Group 3 Version 3100001493

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Daily Change in log10 Colony-forming Unit (CFU)

Negative daily change in log10 CFU indicate decreases in bacterial burden over the 7 day period. Defined as EBA0-7(CFU) = [Day 7 log10 CFU per mL - baseline log10 CFU per mL]/7. The baseline measure is the mean of the pre-entry visit and entry visit sputum colony counts. (NCT01936831)
Timeframe: Measured at baseline and Day 7

Interventionlog10 CFU per mL sputum per day (Mean)
Group 1: 5mg Cohort-0.06
Group 1: 10mg Cohort-0.18
Group 1: 15mg Cohort-0.21
Group 2: 5mg Cohort-0.15

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Daily Change in Time to Positivity (TTP)

"The time to positivity (TTP) measures growth of mycobacterium tuberculosis using MGIT assay in hours. Higher values of daily change in TTP indicate greater decrease in bacterial burden over the 7 day period and is therefore better.~Daily change is defined as EBA0-7(TTP) = [Day 7 TTP - Baseline TTP]/7. Baseline is the mean of the pre-entry visit and entry visit TTPs." (NCT01936831)
Timeframe: Measured at baseline and Day 7

Interventionhours per day (Mean)
Group 1: 5mg Cohort3
Group 1: 10mg Cohort8
Group 1: 15mg Cohort10
Group 2: 5mg Cohort10
Group 3: 15mg Cohort2.0
Group 3: 20mg Cohort4.6

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INH PK Parameter Area Under the Concentration Time Curve (AUC 0-24 Hours)

AUC 0-24h defines area under the concentration-time curve over the period of 24 hours post-dose, estimated through non-compartmental methods using the linear trapezoidal rule. (NCT01936831)
Timeframe: Intensive INH PK samples collected on Day 6 of INH initiation at sample times pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose.

Interventionug*hr/mL (Median)
Group 1: 5mg Cohort14.05
Group 1: 10mg Cohort53.08
Group 1: 15mg Cohort50.24
Group 2: 5mg Cohort10.47
Group 3: 15mg Cohort54.13
Group 3: 20mg Cohort70.54

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INH PK Parameter Maximum Plasma Concentration (Cmax)

Cmax defines maximum concentration observed over the 24 hours of the INH dosing interval. (NCT01936831)
Timeframe: Intensive INH PK samples collected on Day 6 of INH initiation at sample times pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose.

Interventionug/mL (Median)
Group 1: 5mg Cohort5.26
Group 1: 10mg Cohort10.4
Group 1: 15mg Cohort15.1
Group 2: 5mg Cohort4.55
Group 3: 15mg Cohort15
Group 3: 20mg Cohort22.15

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INH PK Parameter Minimum Plasma Concentration (Cmin)

Cmin defines minimum concentration observed over the 24 hours of the INH dosing interval. (NCT01936831)
Timeframe: Intensive INH PK samples collected on Day 6 of INH initiation at sample times pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose.

Interventionug/mL (Median)
Group 1: 5mg Cohort0.053
Group 1: 10mg Cohort0.053
Group 1: 15mg Cohort0.053
Group 2: 5mg Cohort0.053
Group 3: 15mg Cohort0.053
Group 3: 20mg Cohort0.053

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Proportions of Participants Estimated to Have a Drop in log10 CFU/mL at or Above 0.65 log10 CFU/mL.

Proportions of participants obtained through simulation using the estimated model who have a drop in log10 CFU/mL at or above the threshold of 0.65 log10 CFU/mL; 0.65 is half the drop in log10 CFU/mL observed in participants with DS-TB (Group 2) on day 7. A total of 10000 simulated pseudo-participants per arm were used based on data from the study participants. The NAT2 genotype distribution was based only on Group 1 and 2 participants since NAT2 genotype data was not available for Group 3. The simulations were run repeatedly. The point estimate of the proportion was based on the median proportion of the pseudo-individuals across the repeated simulations and the 90% confidence interval used the 5th and 95th percentiles of the proportion across the repeated simulations. (NCT01936831)
Timeframe: From baseline through day 7

Interventionproportion of simulated participants (Median)
Group 1: 5mg Cohort0.17
Group 1: 10mg Cohort0.50
Group 1: 15mg Cohort0.64
Group 2: 5mg Cohort0.88
Group 3: 15mg Cohort0.01
Group 3: 20mg Cohort0.05

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Daily Change in log10 CFU Measured by Early- (EBA0-2) and Late-phase (EBA2-7) Individual-based Parameter Estimates From Nonlinear Models

Negative daily change in log10 CFU indicate decreases in bacterial burden over the time period. The mean CFU are estimated using all values by fitting a biphasic regression models for each participant. The daily change for the first two days of treatment was calculated as EBA0-2 (CFU)= [Day 2 log10 CFU per mL - baseline log10 CFU per mL]/2. The daily change from day 2 to day 7 was calculated as EBA2-7 (CFU)= [Day 7 log10 CFU per mL - Day 2 log10 CFU per mL]/5. Baseline is the average of pre-entry and entry visits. (NCT01936831)
Timeframe: At baseline, day 2, and day 7

,,,
Interventionlog10 CFU per mL sputum per day (Mean)
EBA(0-2)EBA(2-7)
Group 1: 10mg Cohort-0.17-0.17
Group 1: 15mg Cohort-0.13-0.25
Group 1: 5mg Cohort-0.23-0.01
Group 2: 5mg Cohort-0.41-0.07

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Absorption (ka) of INH

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~• Estimated a single absorption rate constant (ka) for the whole population" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

Interventionhr-1 (Mean)
All Cohorts1.74

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Absorption Rate Constant (ka) for Rifapentine (RPT)

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption~Estimated the transit compartment rate constant (ktr), which is synonymous with the absorption constant (ka), for the whole population Note that the mean stated below is actually the value that is obtained from a population analysis and represents a population estimate" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

Interventionhr-1 (Mean)
All Cohorts1.43

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Clearance Relative to Bioavailability (CL/F) for Rifapentine (RPT)

"PK parameters from postpartum women were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption~Calculated an average CL for all post-partum individuals" (NCT02651259)
Timeframe: Data used in the population PK analysis for postpartum women included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

InterventionL/hr (Mean)
All Cohorts1.64

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Clearance Relative to Bioavailability (CL/F) for Rifapentine (RPT) for Intensive and Sparse PK

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption~Calculated an average CL for all women in the 2nd trimester (cohort I) and all women in the 3rd trimester (cohort II)" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

InterventionL/hr (Mean)
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)1.4
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)1.50

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Clearance Relative to Bioavailability (CLmet/F) for Desacetyl Rifapentine (Des-RPT)

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption and a separate compartment for metabolite formation~Estimated a single des-RPT CLmet/F for the whole population Note: that the mean stated below is actually the value that is obtained from a population analysis and represents a population estimate with the relative standard error" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

InterventionL/hr (Mean)
All Cohorts2.82

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Cord Blood Concentrations of Desacetyl Rifapentine (Des-RPT) Among Infants

Cord blood concentrations were summarized using using R (version 3.5.1). (NCT02651259)
Timeframe: at delivery (within 3 days of life for infants).

Interventionmcg/mL (Mean)
All Cohorts3.24

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Cord Blood Concentrations of Rifapentine (RPT) Among Infants

Cord blood concentrations were summarized using using R (version 3.5.1). (NCT02651259)
Timeframe: at delivery - (within 3 days of life for infants)

Interventionmcg/mL (Mean)
All Cohorts2.97

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Number of Infants With Active TB up to 24 Weeks of Life

Based on site-specified confirmatory TB test. If women and infants were diagnosed with active TB during study they would be referred to local care for TB management and treatment. (NCT02651259)
Timeframe: Measured from birth through participants' last study visit at 24 weeks after delivery

InterventionParticipants (Count of Participants)
Cohort 1(Infants Born to Women Enrolled in Second Trimester)0
Cohort 2 (Infants Born to Women Enrolled in Third Trimester)0

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Number of Mothers With Active TB up to 24 Weeks Postpartum

Based on site-specified confirmatory TB test. If women and infants were diagnosed with active TB during study they would be referred to local care for TB management and treatment. (NCT02651259)
Timeframe: Measured from study entry through participants' last study visit at 24 weeks after delivery

InterventionParticipants (Count of Participants)
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)0
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)0

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Number of Participants With Discontinuation of Study Drug Due to Intolerance (Tolerability of Study Drug Regimen - i.e., RPT, INH, and Pyridoxine)

At entry and follow-up, all lab results, sign and symptoms, and diagnoses will be recorded. Also, during follow-up grade 2 events related to pregnancy complications, hepatotoxicity, hemorrhage, or peripheral neuropathy, and all grade 3 or events that result in discontinuation of study drug regimen, and that meet criteria for EAE reporting will be further evaluated and recorded. The DAIDS Table for Grading Adult and Pediatric Adverse Events (V 2.0) and Expedited AE Manual (V 2.0) were used. (NCT02651259)
Timeframe: Measured from study entry through participants' last study visit at 24 weeks after delivery

InterventionParticipants (Count of Participants)
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)0
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)0

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Percentage of Participants With All AEs Leading to Permanent Discontinuation of Study Drug Regimen (i.e., RPT, INH, and Pyridoxine)

At entry and follow-up, all lab results, sign and symptoms, and diagnoses were recorded. Also, during follow-up grade 2 events related to pregnancy complications, hepatotoxicity, hemorrhage, or peripheral neuropathy, and all grade 3 or events that resulted in discontinuation of study drug regimen, and that met criteria for EAE reporting would further be evaluated and recorded. The DAIDS Table for Grading Adult and Pediatric Adverse Events (V 2.0) and Expedited AE Manual (V 2.0) were used. (NCT02651259)
Timeframe: Measured from study entry through participants' last study treatment dispensation (approximately for 12 weeks)

Interventionpercent of participants (Number)
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)0
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)0

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Percentage of Participants With All Grade 3 and 4 AEs

At entry and follow-up, all lab results, sign and symptoms, and diagnoses were recorded. Also, during follow-up grade 2 events related to pregnancy complications, hepatotoxicity, hemorrhage, or peripheral neuropathy, and all grade 3 or events that resulted in discontinuation of study drug regimen, and that met criteria for EAE reporting would further be evaluated and recorded. The DAIDS Table for Grading Adult and Pediatric Adverse Events (V 2.0) and Expedited AE Manual (V 2.0) were used. (NCT02651259)
Timeframe: Measured from study entry through participants' last study visit at 24 weeks after delivery

Interventionpercent of participants (Number)
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)20
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)16

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Percentage of Participants With All Serious AEs

At entry and follow-up, all lab results, sign and symptoms, and diagnoses were recorded. Also, during follow-up grade 2 events related to pregnancy complications, hepatotoxicity, hemorrhage, or peripheral neuropathy, and all grade 3 or events that resulted in discontinuation of study drug regimen, and that met criteria for EAE reporting would further be evaluated and recorded. The DAIDS Table for Grading Adult and Pediatric Adverse Events (V 2.0) and Expedited AE Manual (V 2.0) were used. (NCT02651259)
Timeframe: Measured from study entry through participants' last study visit at 24 weeks after delivery

Interventionpercent of participants (Number)
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)8
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)12

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Plasma Concentrations of Desacetyl Rifapentine (Des-RPT) Among Infants

Plasma blood concentrations were summarized using using R (version 3.5.1). (NCT02651259)
Timeframe: at delivery - (within 3 days of life for infants).

Interventionmcg/mL (Mean)
All Cohorts5.31

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Plasma Concentrations of Rifapentine (RPT) Among Infants

Plasma concentrations were summarized using using R (version 3.5.1). (NCT02651259)
Timeframe: at delivery - (within 3 days of life for infants).

Interventionmcg/mL (Mean)
All Cohorts2.47

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Volume of Distribution of INH

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~• Estimated a single INH Vc/F for the whole population" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

InterventionL (Mean)
All Cohorts107

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Volume of Distribution Relative to Bioavailability (Vc/F) for Rifapentine (RPT)

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption~Estimated a single RPT Vc/F for for the whole population Note: that the mean stated below is actually the value that is obtained from a population analysis and represents a population estimate with the relative standard error" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

InterventionL (Mean)
All Cohorts30.1

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Area Under the Curve From 0 to 24 Hours (AUC0-24) for RPT and Area Under the Curve From 0 to 24 Hours (AUC0-24) for Des-RPT Pregnant Women in 2nd and 3rd Trimester

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption~Obtained AUC by model-based integration" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

,
Interventionhour*mg/L (Mean)
AUC (0-24) for RPTAUC (0-24) for des-RPT
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)424.7158.7
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)406.8153.7

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Clearance (CL/F) of INH

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with 2 mixtures to characterize subpopulations based on acetylation status~Estimated a separate INH CL/F based on acetylation status (fast, slow)" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

InterventionL/hr (Mean)
CL/F (slow acetylators)CL/F (fast acetylators)
All Cohorts8.9832.7

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Maximum Concentration (Cmax) for RPT Maximum Concentration (Cmax) for Des-RPT Pregnant Women in 2nd and 3rd Trimester

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption~Obtained Cmax by model-based estimation" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

,
Interventionmg/L (Mean)
Cmax for RPTCmax for des-RPT
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)30.28.76
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)28.68.50

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Maximum Concentration (Cmin) for RPT and Maximum Concentration (Cmin) for Des-RPT Pregnant Women in 2nd and 3rd Trimester

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption~Obtained Cmin by model-based estimation" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

,
Interventionmg/L (Mean)
Cmin for RPTCmin for des-RPT
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)1.451.06
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)1.581.20

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Number of Participants Who Permanently Discontinue Assigned Study Regimen for Any Reason

(Other than new recognition of participant ineligibility based on absence of M. tuberculosis growth in baseline sputum cultures, or growth of M. tuberculosis resistant to rifampin by GeneXpert) (NCT03882177)
Timeframe: Measured through Day 14

InterventionParticipants (Count of Participants)
Arm 1: Pravastatin (40 mg) and Rifafour10
Arm 2: Pravastatin (80 mg) and Rifafour6
Arm 3: Pravastatin (120 mg) and Rifafour0
Arm 4: Pravastatin (160 mg) and Rifafour0

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Frequency of Grade 3 or Higher Adverse Events

Graded using the DAIDS table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (NCT03882177)
Timeframe: Measured through Day 30

InterventionAEs Grade 3 or Higher (Number)
Arm 1: Pravastatin (40 mg) and Rifafour8
Arm 2: Pravastatin (80 mg) and Rifafour4

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