phenylacetic acid has been researched along with Benign Neoplasms in 13 studies
phenylacetic acid : A monocarboxylic acid that is toluene in which one of the hydrogens of the methyl group has been replaced by a carboxy group.
| Excerpt | Relevance | Reference |
|---|---|---|
| " PAA plasma levels ≥ 500 μg/dL have been reported to be associated with reversible neurological adverse events (AEs) in cancer patients receiving PAA intravenously." | 5.39 | Elevated phenylacetic acid levels do not correlate with adverse events in patients with urea cycle disorders or hepatic encephalopathy and can be predicted based on the plasma PAA to PAGN ratio. ( Bartley, J; Berquist, W; Berry, SA; Brown, RS; Coakley, D; Diaz, GA; Dickinson, K; Feigenbaum, A; Gallagher, R; Ghabril, M; Harding, C; Lee, B; Lemons, C; Lichter-Konecki, U; Longo, N; Mantry, P; McCandless, SE; Milikien, DA; Mokhtarani, M; Moors, T; Nagamani, SC; Norris, C; Rhead, W; Rockey, DC; Scharschmidt, BF; Schulze, A; Smith, W; Vierling, JM, 2013) |
| " We performed a pharmacokinetic study, as part of a phase I trial, of PAA in children with refractory cancer." | 2.71 | Pharmacokinetics of phenylacetate administered as a 30-min infusion in children with refractory cancer. ( Adamson, P; Aiken, A; Balis, F; Berg, S; Blaney, SM; Jakacki, R; Klenke, R; Murry, DJ; Packer, R; Serabe, BM; Thompson, P, 2003) |
| " bioavailability determination." | 2.70 | A phase I dose escalation and bioavailability study of oral sodium phenylbutyrate in patients with refractory solid tumor malignancies. ( Baker, SD; Bowling, MK; Carducci, MA; Donehower, RC; Figg, WD; Gilbert, J; Grochow, L; Zabelina, Y, 2001) |
| "Fourteen patients with cancer (aged 51." | 2.68 | Disposition of phenylbutyrate and its metabolites, phenylacetate and phenylacetylglutamine. ( Figg, WD; Headlee, D; Lieberman, R; Myers, CE; Piscitelli, SC; Samid, D; Thibault, A; Tompkins, A, 1995) |
| "Patients with cancer with lower levels of albumin showed an increase in free fraction with both phenylacetate and phenylbutyrate." | 2.68 | Plasma protein binding of phenylacetate and phenylbutyrate, two novel antineoplastic agents. ( Boudoulas, S; Figg, WD; Lush, RM; McCall, NA; Reed, E; Samid, D, 1996) |
| " One of six patients with glioblastoma multiforme, whose steroid dosage has remained unchanged for the duration of therapy, has sustained functional improvement for more than 9 months." | 2.67 | A phase I and pharmacokinetic study of intravenous phenylacetate in patients with cancer. ( Cooper, MR; Figg, WD; Headlee, DJ; McCall, NA; Samid, D; Sartor, AO; Thibault, A; Tompkins, AC; Venzon, DJ; Weinberger, MS, 1994) |
| " PAA plasma levels ≥ 500 μg/dL have been reported to be associated with reversible neurological adverse events (AEs) in cancer patients receiving PAA intravenously." | 1.39 | Elevated phenylacetic acid levels do not correlate with adverse events in patients with urea cycle disorders or hepatic encephalopathy and can be predicted based on the plasma PAA to PAGN ratio. ( Bartley, J; Berquist, W; Berry, SA; Brown, RS; Coakley, D; Diaz, GA; Dickinson, K; Feigenbaum, A; Gallagher, R; Ghabril, M; Harding, C; Lee, B; Lemons, C; Lichter-Konecki, U; Longo, N; Mantry, P; McCandless, SE; Milikien, DA; Mokhtarani, M; Moors, T; Nagamani, SC; Norris, C; Rhead, W; Rockey, DC; Scharschmidt, BF; Schulze, A; Smith, W; Vierling, JM, 2013) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 6 (46.15) | 18.2507 |
| 2000's | 5 (38.46) | 29.6817 |
| 2010's | 2 (15.38) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Figg, WD | 6 |
| Mokhtarani, M | 1 |
| Diaz, GA | 1 |
| Rhead, W | 1 |
| Berry, SA | 1 |
| Lichter-Konecki, U | 1 |
| Feigenbaum, A | 1 |
| Schulze, A | 1 |
| Longo, N | 1 |
| Bartley, J | 1 |
| Berquist, W | 1 |
| Gallagher, R | 1 |
| Smith, W | 1 |
| McCandless, SE | 1 |
| Harding, C | 1 |
| Rockey, DC | 1 |
| Vierling, JM | 1 |
| Mantry, P | 1 |
| Ghabril, M | 1 |
| Brown, RS | 1 |
| Dickinson, K | 1 |
| Moors, T | 1 |
| Norris, C | 1 |
| Coakley, D | 1 |
| Milikien, DA | 1 |
| Nagamani, SC | 1 |
| Lemons, C | 1 |
| Lee, B | 1 |
| Scharschmidt, BF | 1 |
| Sidell, N | 1 |
| Hao, L | 1 |
| Pasquali, M | 1 |
| McDonald, JD | 1 |
| Thompson, P | 1 |
| Balis, F | 1 |
| Serabe, BM | 1 |
| Berg, S | 1 |
| Adamson, P | 1 |
| Klenke, R | 1 |
| Aiken, A | 1 |
| Packer, R | 1 |
| Murry, DJ | 1 |
| Jakacki, R | 1 |
| Blaney, SM | 1 |
| Piscitelli, SC | 1 |
| Thibault, A | 4 |
| Tompkins, A | 1 |
| Headlee, D | 1 |
| Lieberman, R | 1 |
| Samid, D | 6 |
| Myers, CE | 3 |
| Cooper, MR | 2 |
| Tompkins, AC | 2 |
| Patronas, N | 1 |
| Headlee, DJ | 2 |
| Kohler, DR | 1 |
| Venzon, DJ | 2 |
| Sartor, AO | 1 |
| Weinberger, MS | 1 |
| McCall, NA | 2 |
| Larsen, NS | 1 |
| Boudoulas, S | 1 |
| Lush, RM | 1 |
| Reed, E | 1 |
| Hudgins, WR | 1 |
| Shack, S | 1 |
| Liu, L | 1 |
| Prasanna, P | 1 |
| Wells, M | 1 |
| Greene, ME | 1 |
| Shen, W | 1 |
| Palmer, CN | 1 |
| Gilbert, J | 2 |
| Baker, SD | 1 |
| Bowling, MK | 2 |
| Grochow, L | 1 |
| Zabelina, Y | 2 |
| Donehower, RC | 2 |
| Carducci, MA | 2 |
| Noe, D | 1 |
| Eisenberger, MA | 1 |
| Sinibaldi, V | 1 |
| Chen, TL | 1 |
| Grochow, LB | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase 2, Fixed-Sequence, Open-Label, Switch-Over Study of the Safety and Tolerability of HPN-100 Compared to Sodium Phenylbutyrate in Children 6-17 Years of Age With Urea Cycle Disorders, With a Long-Term Safety Extension[NCT00947544] | Phase 2 | 17 participants (Actual) | Interventional | 2010-03-31 | Completed | ||
| A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of HPN-100 for Maintaining Remission in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy[NCT00999167] | Phase 2 | 189 participants (Actual) | Interventional | 2009-12-31 | Completed | ||
| A Phase 3, Randomized, Double-Blind, Cross-Over, Active-Controlled Study of the Efficacy and Safety of HPN-100, Glyceryl Tri-(4-phenylbutyrate), for the Treatment of Adults With Urea Cycle Disorders (Help UCD)[NCT00992459] | Phase 3 | 46 participants (Actual) | Interventional | 2009-10-31 | Completed | ||
| A Phase 3, Open-Label Study of the Safety of HPN-100 for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD)[NCT00947297] | Phase 3 | 60 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
| A Switch-Over, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of HPN-100, Followed by Long-Term Treatment With HPN-100, in Pediatric Subjects Under 6 Years of Age With Urea Cycle Disorders (UCDs)[NCT01347073] | Phase 3 | 23 participants (Actual) | Interventional | 2011-07-31 | Completed | ||
| A Phase 2, Open-Label, Switch-Over, Dose-Escalation Study of the Safety and Tolerability of HPN-100 Compared to Buphenyl® (Sodium Phenylbutyrate) in Patients With Urea Cycle Disorders[NCT00551200] | Phase 2 | 14 participants (Actual) | Interventional | 2007-10-31 | Completed | ||
| A Phase I Study of Entinostat in Combination With Enzalutamide for Treatment of Patients With Castration-Resistant Prostate Cancer[NCT03829930] | Phase 1 | 6 participants (Actual) | Interventional | 2019-05-01 | Terminated (stopped due to Sponsor discontinued the drug) | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100). (NCT00947544)
Timeframe: Day 7 (NaPBA) and Day 14 (HPN-100)
| Intervention | µmol/L (Mean) |
|---|---|
| HPN-100 | 28.68 |
| NaPBA | 37.75 |
To evaluate control of blood ammonia by HPN-100 compared with NaPBA in pediatric patients with UCDs. (NCT00947544)
Timeframe: Day 7 (NaPBA) and Day 14 (HPN-100)
| Intervention | μmol∙h/L (Mean) |
|---|---|
| HPN-100 | 603.83 |
| NaPBA | 814.62 |
blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100). (NCT00947544)
Timeframe: Day 7 (NaPBA) and Day 14 (HPN-100)
| Intervention | μmol/L (Mean) |
|---|---|
| HPN-100 | 47.77 |
| NaPBA | 55.66 |
blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100). (NCT00947544)
Timeframe: Day 7 (NaPBA) and Day 14 (HPN-100)
| Intervention | μg•h/mL AUC 0-24 (Mean) |
|---|---|
| HPN-100 | 964 |
| NaPBA | 773 |
blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100). (NCT00947544)
Timeframe: Day 7 (NaPBA) and Day 14 (HPN-100)
| Intervention | μg*h/mL AUC 0-24 (Mean) |
|---|---|
| HPN-100 | 1378 |
| NaPBA | 1015 |
blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100). (NCT00947544)
Timeframe: Day 7 (NaPBA) and Day 14 (HPN-100)
| Intervention | µg*h/ml AUC 0-24 (Mean) |
|---|---|
| HPN-100 | 631 |
| NaPBA | 236 |
"change from baseline to Month 12.~The SF 15 questionnaire consists of 15 questions that assess the following:~Physical functioning (5 questions)~Emotional functioning (4 questions)~Social functioning (3 questions)~School functioning (3 questions) Items were scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or a 3-point scale (0 [not at all], 2 [sometimes], or 4 [a lot] for the young child self-report). Items were reverse-scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score was 0-100 scale (averaged from each functional areas). In the 0-100 scale, 0 is the worst score and 100 is best score.~Improved quality of life was shown by increased total score from baseline to Month 12." (NCT00947544)
Timeframe: 1 year
| Intervention | score on a scale (Mean) |
|---|---|
| HPN-100 | 4.0 |
blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100). (NCT00947544)
Timeframe: Day 7 (NaPBA) and Day 14 (HPN-100)
| Intervention | percentage of sample (Number) |
|---|---|
| HPN-100 | 18.4 |
| NaPBA | 31.6 |
To evaluate the safety and PK characteristics of HPN-100 compared with sodium phenylbutyrate (NaPBA) in pediatric patients with urea cycle disorders (UCDs) (NCT00947544)
Timeframe: 1 week on each treatment for a total of 2 week.
| Intervention | participants (Number) |
|---|---|
| HPN-100 | 4 |
| NaPBA | 2 |
Urinary PAGN (phenylacetylglutamine) 24-hour excretion. Urine was collect during 0-12 hrs and 12-24 hrs. (NCT00947544)
Timeframe: Day 7 (NaPBA) and Day 14 (HPN-100)
| Intervention | μg (Mean) |
|---|---|
| HPN-100 | 12501037 |
| NaPBA | 12512426 |
"Number of Subjects with at Least One Hyperammonemic Crisis.~Hyperammonemic crisis is defined as follows:~• Clinical symptoms associated with ammonia of ≥ 100 µmol/L" (NCT00947544)
Timeframe: 1 year
| Intervention | participants (Number) | |
|---|---|---|
| Number of subjects with at least 1 HAC | Number of Crises | |
| Pre-Enrollment (NaPBA) | 5 | 8 |
| Safety Extension (HPN-100) | 3 | 3 |
"An HE event was defined as occurrences of either a West Haven (WH) Grade ≥2 or a WH Grade 1 and asterixis grade increase of 1 (if baseline WH = 0).~The WH criteria are widely used for rating the severity of HE and are summarized below:~Grade 1: trivial lack of awareness, euphoria or anxiety, shortened attention span, impaired performance of addition Grade 2: lethargy or apathy, minimal disorientation for time or place, subtle personality change, inappropriate behavior, impaired performance of subtraction Grade 3: somnolence to semi-stupor but responsive to verbal stimuli, confusion, gross disorientation Grade 4: coma (unresponsive to verbal or noxious stimuli)~Asterixis was assessed after arm and forearm extension along with wrist dorsiflexion for 30 seconds and assigned a grade according to the following criteria:~Grade 1: rare flaps Grade 2: occasional irregular flaps Grade 3: frequent flaps Grade 4: continuous flaps" (NCT00999167)
Timeframe: Part B: 112 Days
| Intervention | participants (Number) |
|---|---|
| HPN-100 | 19 |
| Placebo | 32 |
Secondary efficacy endpoint. The time to the first HE episode during the treatment period was calculated using the Kaplan-Meier method. Subjects who did not experience an HE episode were censored at the time of their last asterixis assessment. Subjects who had no post-randomization data for the primary endpoint were considered to have an HE episode at Day 1. (NCT00999167)
Timeframe: 112 Days
| Intervention | Days (Median) |
|---|---|
| HPN-100 | NA |
| Placebo | NA |
Secondary efficacy endpoint. The total number of HE events during the treatment phase for subjects in the placebo and active arms. (NCT00999167)
Timeframe: 112 Days
| Intervention | HE event (Number) |
|---|---|
| HPN-100 | 35 |
| Placebo | 57 |
Changes from Baseline to Day 56 and the Final Visit were compared between treatment groups using an ANCOVA model for the total index RBANS score ). The index score is a sum of the scores for each of the 5 individual domains (immediate memory, visuospatial/constructional, language, attention). The minimum and maximum total index scores are 40 and 160, respectively; a higher score is better. (NCT00999167)
Timeframe: Day 56, Final Visit (D112)
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Change from Baseline to D56 (Total Score) | Change from Baseline to Final Visit (Total Score) | |
| HPN-100 | -0.5 | -10.7 |
| Placebo | 3.2 | -9.7 |
Part A: The rate of AEs and tolerability of 6 mL and 9 mL doses of HPN-100 were considered the primary safety endpoints for Part A. Safety assessments included adverse events, laboratory tests (including ammonia, hematology, coagulation, liver function and serum chemistry parameters), vital signs, physical and neurological examinations, and electrocardiograms. (NCT00999167)
Timeframe: Part A: 28 days
| Intervention | Subjects (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Any AE | Gastrointestinal disorders | Metabolism and nutrition disorders | Infection and infestations | Nervous system disorders | Blood and lymphatic system disorders | Injury, poisoning and procedural complications | Musculoskeletal and connective tissue disorders | Psychiatric disorders | Any SAE | Death | |
| HPN-100 BID | 11 | 9 | 7 | 4 | 4 | 2 | 2 | 2 | 2 | 5 | 2 |
Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28. (NCT00992459)
Timeframe: pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28
| Intervention | μg/mL (Mean) |
|---|---|
| NaPBA | 52.2 |
| HPN-100 | 38.5 |
Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28. (NCT00992459)
Timeframe: pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28
| Intervention | μg/mL (Mean) |
|---|---|
| NaPBA | 80.9 |
| HPN-100 | 51.9 |
Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28. (NCT00992459)
Timeframe: pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28
| Intervention | μg/mL (Mean) |
|---|---|
| NaPBA | 78.6 |
| HPN-100 | 86.8 |
The correlation between 24-hour urinary phenylacetylglutamine (PAGN) excretion (U-PAGN24-hour Excr) and venous ammonia AUC0-24 was summarized and the correlation was tested using the Spearman rank-order correlation. (NCT00992459)
Timeframe: 28 Days
| Intervention | correlation coefficient (Number) |
|---|---|
| NaPBA | 0.437 |
| HPN-100 | 0.219 |
Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28. (NCT00992459)
Timeframe: pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28
| Intervention | µmol/L (Mean) |
|---|---|
| NaPBA | 70.83 |
| HPN-100 | 60.94 |
Severity of symptomatic hyperammonemic crises was measured by peak ammonia level (µmol/L) when it is >= 100 µmol/L. (NCT00992459)
Timeframe: 29 Days
| Intervention | events (Number) |
|---|---|
| NaPBA | 1 |
| HPN-100 | 0 |
NaPBA treated arm: total 345 blood samples were collected. HPN-100 treated arm: 343 blood samples were collected. (NCT00992459)
Timeframe: on Day 14 and Day 28
| Intervention | samples (Number) |
|---|---|
| NaPBA | 125 |
| HPN-100 | 122 |
(NCT00992459)
Timeframe: 29 Days
| Intervention | participants (Number) |
|---|---|
| NaPBA | 23 |
| HPN-100 | 27 |
Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28. Arm A day 14 and Arm B day 28 data were combined as a NaPBA treatment Arm. Arm B day 14 and Arm A day 28 data were combined as a HPN-100 treatment Arm. (NCT00992459)
Timeframe: pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28
| Intervention | μmol∙h/L (Mean) |
|---|---|
| NaPBA | 976.6 |
| HPN-100 | 865.35 |
(NCT00992459)
Timeframe: 24 hours on Day 14 of each treatments
| Intervention | μg (Mean) |
|---|---|
| NaPBA | 13627515 |
| HPN-100 | 13502745 |
Number of hyperammonemic crises per patient (NCT00947297)
Timeframe: 1 year
| Intervention | hyperammonemic events (Mean) |
|---|---|
| HPN-100 | 0.20 |
Drug preference will be noted at week 3 (NCT00947297)
Timeframe: Month 1 post dose
| Intervention | % preferred HPN-100 (Number) |
|---|---|
| HPN-100 | 90 |
(NCT00947297)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|---|
| HPN-100 | 33 |
Venous Ammonia levels over time (NCT00947297)
Timeframe: 1 Year
| Intervention | Umol/L (Mean) | |
|---|---|---|
| Baseline | Month 12 | |
| HPN-100 | 27.623 | 24.202 |
Rate of adverse events during the Safety Extension portion of the protocol ( please note: HPN-100 treatment only during Safety Extension ) (NCT01347073)
Timeframe: 12 months
| Intervention | participants (Number) |
|---|---|
| HPN-100 | 23 |
Rate of adverse events during the Switch-Over portion of the Protocol (NCT01347073)
Timeframe: 2 weeks
| Intervention | participants (Number) |
|---|---|
| NaPBA | 0 |
| HPN-100 | 6 |
24-hour ammonia AUC of blood ammonia levels on Days 1 (NaPBA) and 10 (HPN-100) were compared. Ammonia was assessed at Hour 0 (pre-first dose, fasted), Hour 8 (~2-4 hours after lunch or the second main meal and dose of NaPBA), Hour 12 (~4 hours after the last main meal) and 24 hours post-first dose (pre-first dose on following day, fasted). (NCT01347073)
Timeframe: 2 weeks
| Intervention | umol/L*hours (Mean) |
|---|---|
| NaPBA | 914.43 |
| HPN-100 | 647.63 |
Ammonia values were converted to SI units (umol/L) and normalized to a standard ULN of 35 umol/L prior to analysis (NCT01347073)
Timeframe: 2 weeks
| Intervention | Ammonia Values > ULN (Number) |
|---|---|
| NaPBA | 22 |
| HPN-100 | 8 |
Rate of HAC during pre-enrollment on NaPBA compared to HAC during HPN-100 treatment (NCT01347073)
Timeframe: 1 year
| Intervention | number of crises (Number) |
|---|---|
| Pre-enrollment | 29 |
| Long-term Phase | 12 |
(NCT00551200)
Timeframe: during the period on 100% Buphenyl (up to 4 weeks) or HPN-100 (up to 10 weeks)
| Intervention | participants (Number) |
|---|---|
| Buphenyl | 7 |
| HPN-100 | 5 |
(NCT00551200)
Timeframe: during the period subjects on 100% Buphenyl (up to 4 weeks) or HPN-100 (up to 10 weeks)
| Intervention | participants (Number) |
|---|---|
| Buphenyl | 1 |
| HPN-100 | 0 |
(NCT00551200)
Timeframe: End of Study
| Intervention | participants (Number) | |
|---|---|---|
| prefer Buphenyl | prefer HPN-100 | |
| Buphenyl to HPN-100 | 1 | 9 |
measured AUC0-24 (Area under the curve from time 0 (pre-dose) to 24 hours) for each metabolite in plasma. Data were collected at 30 minutes and 1, 2, 4, 5, 6, 8, 10, 12, and 24 hours post-first dose. (NCT00551200)
Timeframe: At steady state (1 week) on each medication (Buphenyl® alone, HPN-100 alone)
| Intervention | μg*h/mL (Mean) | ||
|---|---|---|---|
| AUC0-24 PBA (phenylbutyrate) in plasma | AUC0-24 PAA (phenylacetate) in plasma | AUC0-24 PAGN (phenylacetylglutamine) in plasma | |
| HPN-100 Steady State | 540 | 575 | 1098 |
| NaPBA Steady State | 740 | 596 | 1133 |
Data were collected at pre-first dose and at 30 minutes and 1, 2, 4, 5, 6, 8, 10, 12, and 24 hours post first dose. (NCT00551200)
Timeframe: At steady state (1 week) on each medication (Buphenyl® alone, HPN-100 alone), and at steady state (1 week) after each dose escalation
| Intervention | μmol/L (Mean) | |
|---|---|---|
| in peak | in TNAUC (time-normalized area under the curve) | |
| HPN-100 Steady State | 56.3 | 26.5 |
| NaPBA Steady State | 79.1 | 38.4 |
1 review available for phenylacetic acid and Benign Neoplasms
| Article | Year |
|---|---|
Phenylacetate and phenylbutyrate as novel, nontoxic differentiation inducers.
Topics: Adult; Antimetabolites, Antineoplastic; Brain Neoplasms; Cell Differentiation; Clinical Trials, Phas | 1997 |
7 trials available for phenylacetic acid and Benign Neoplasms
| Article | Year |
|---|---|
Pharmacokinetics of phenylacetate administered as a 30-min infusion in children with refractory cancer.
Topics: Adolescent; Adult; Antineoplastic Agents; Biotransformation; Child; Child, Preschool; Chromatography | 2003 |
Disposition of phenylbutyrate and its metabolites, phenylacetate and phenylacetylglutamine.
Topics: Adult; Aged; Female; Glutamine; Humans; Male; Middle Aged; Models, Biological; Neoplasms; Phenylacet | 1995 |
Phase I study of phenylacetate administered twice daily to patients with cancer.
Topics: Adult; Aged; Antineoplastic Agents; Drug Administration Schedule; Female; Humans; Infusions, Intrave | 1995 |
A phase I and pharmacokinetic study of intravenous phenylacetate in patients with cancer.
Topics: Adult; Aged; Antineoplastic Agents; Brain Neoplasms; Drug Administration Schedule; Female; Glioblast | 1994 |
Plasma protein binding of phenylacetate and phenylbutyrate, two novel antineoplastic agents.
Topics: Adult; Antimetabolites, Antineoplastic; Humans; Hydrogen-Ion Concentration; Neoplasms; Phenylacetate | 1996 |
A phase I dose escalation and bioavailability study of oral sodium phenylbutyrate in patients with refractory solid tumor malignancies.
Topics: Administration, Oral; Adult; Aged; Area Under Curve; Biological Availability; Dose-Response Relation | 2001 |
A Phase I clinical and pharmacological evaluation of sodium phenylbutyrate on an 120-h infusion schedule.
Topics: Adult; Antineoplastic Agents; Chromatography, High Pressure Liquid; Disorders of Excessive Somnolenc | 2001 |
5 other studies available for phenylacetic acid and Benign Neoplasms