Page last updated: 2024-10-29

ketoconazole and Long QT Syndrome

ketoconazole has been researched along with Long QT Syndrome in 15 studies

1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine : A dioxolane that is 1,3-dioxolane which is substituted at positions 2, 2, and 4 by imidazol-1-ylmethyl, 2,4-dichlorophenyl, and [para-(4-acetylpiperazin-1-yl)phenoxy]methyl groups, respectively.

Long QT Syndrome: A condition that is characterized by episodes of fainting (SYNCOPE) and varying degree of ventricular arrhythmia as indicated by the prolonged QT interval. The inherited forms are caused by mutation of genes encoding cardiac ion channel proteins. The two major forms are ROMANO-WARD SYNDROME and JERVELL-LANGE NIELSEN SYNDROME.

Research Excerpts

ExcerptRelevanceReference
"Levoketoconazole is a ketoconazole stereoisomer in development for treatment of Cushing's syndrome and has not been assessed previously in a clinical trial in patients with Cushing's syndrome."9.30Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial. ( Auchus, RJ; Biller, BMK; Cohen, F; Elenkova, A; Feelders, RA; Fleseriu, M; Geer, EB; Greenman, Y; Pivonello, R; Salvatori, R; Witek, P, 2019)
"Levoketoconazole is a ketoconazole stereoisomer in development for treatment of Cushing's syndrome and has not been assessed previously in a clinical trial in patients with Cushing's syndrome."5.30Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial. ( Auchus, RJ; Biller, BMK; Cohen, F; Elenkova, A; Feelders, RA; Fleseriu, M; Geer, EB; Greenman, Y; Pivonello, R; Salvatori, R; Witek, P, 2019)
"To assess the steady-state pharmacokinetic and QT(c) effects of domperidone and ketoconazole, given alone and together."2.77Pharmacokinetic interaction between domperidone and ketoconazole leads to QT prolongation in healthy volunteers: a randomized, placebo-controlled, double-blind, crossover study. ( Baisley, KJ; Boyce, MJ; Warrington, SJ, 2012)
"The present clinical trial was designed to evaluate the possible pharmacokinetic and electrocardiographic interactions of the gastroenteric prokinetic drug cinitapride with ketoconazole."2.73The prokinetic cinitapride has no clinically relevant pharmacokinetic interaction and effect on QT during coadministration with ketoconazole. ( Esbri, R; Golor, G; Pavesi, M; Robert, M; Roberts, D; Salvà, M; Segarra, R, 2007)
" The aim of this study was to assess the QT interval in patients with Cushing's disease during long-term administration of ketoconazole."1.43No Untoward Effect of Long-Term Ketoconazole Administration on Electrocardiographic QT Interval in Patients with Cushing's Disease. ( Cavagnini, F; De Martin, M; Goulene, K; Pecori Giraldi, F; Radaelli, P; Stramba-Badiale, M; Toja, PM, 2016)
"Latent tuberculosis infection is an important problem for solid organ transplant recipients because of the frequency of its occurrence and its potential for reactivation."1.39Use of rifabutin for the treatment of a latent tuberculosis infection in a patient after solid organ transplantation. ( Chin-Hong, PV; Hickey, MD; Quan, DJ; Roberts, JP, 2013)

Research

Studies (15)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's1 (6.67)18.2507
2000's9 (60.00)29.6817
2010's5 (33.33)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Fleseriu, M1
Pivonello, R1
Elenkova, A1
Salvatori, R1
Auchus, RJ1
Feelders, RA1
Geer, EB1
Greenman, Y1
Witek, P1
Cohen, F1
Biller, BMK1
Hickey, MD1
Quan, DJ1
Chin-Hong, PV1
Roberts, JP1
De Martin, M1
Toja, PM1
Goulene, K1
Radaelli, P1
Cavagnini, F1
Stramba-Badiale, M1
Pecori Giraldi, F1
Yeung, KS1
Meanwell, NA1
Boyce, MJ1
Baisley, KJ1
Warrington, SJ1
Potkin, SG1
Preskorn, S1
Hochfeld, M1
Meng, X1
Hamlin, RL1
Kijtawornrat, A1
Keene, BW1
Hamlin, DM1
Mok, NS1
Lo, YK1
Tsui, PT1
Lam, CW1
Darpo, B1
Agin, M1
Kazierad, DJ1
Layton, G1
Muirhead, G1
Gray, P1
Jorkasky, DK1
Dumaine, R1
Antzelevitch, C1
Robert, M1
Salvà, M1
Segarra, R1
Pavesi, M1
Esbri, R1
Roberts, D1
Golor, G1
Sarapa, N1
Nickens, DJ1
Raber, SR1
Reynolds, RR1
Amantea, MA1
Takemasa, H1
Nagatomo, T1
Abe, H1
Kawakami, K1
Igarashi, T1
Tsurugi, T1
Kabashima, N1
Tamura, M1
Okazaki, M1
Delisle, BP1
January, CT1
Otsuji, Y1
Zimmermann, M1
Duruz, H1
Guinand, O1
Broccard, O1
Levy, P1
Lacatis, D1
Bloch, A1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
An Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's Syndrome[NCT01838551]Phase 394 participants (Actual)Interventional2014-08-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Normalization in Urinary Free Cortisol in Patients With Endogenous Cushing's Syndrome.

"The response to COR-003 is defined as mean UFC concentration ≤ULN following 6 months of maintenance phase therapy without a prior dose increase during that phase. The proportion of responders at the End of Maintenance Phase visit, following 6 months of treatment in the Maintenance Phase, for all dose groups combined was estimated using a generalized linear model with repeated measurements based on a binomial distribution with a logit link function and with region (US vs. non-US), concurrent CS medical conditions (diabetes [Yes/No], hypertension [Yes/No]), age (rounded median split based on the ITT population), sex, disease duration (years), prior CS medication (Yes/No), prior radiation therapy (Yes/No) as Baseline covariates and visit as an independent factor.~The least squares mean (LSMEAN) estimate of the UFC response after 6 months of treatment in the Maintenance Phase alongside its 95% Wald CI is presented." (NCT01838551)
Timeframe: 6 months of maintenance phase therapy without a prior dose increase during that phase

Interventionproportion of subjects meeting endpoint (Least Squares Mean)
Levoketoconazole All Doses.30

Trials

6 trials available for ketoconazole and Long QT Syndrome

ArticleYear
Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial.
    The lancet. Diabetes & endocrinology, 2019, Volume: 7, Issue:11

    Topics: Adolescent; Adrenal Insufficiency; Adult; Aged; Alanine Transaminase; Chemical and Drug Induced Live

2019
Pharmacokinetic interaction between domperidone and ketoconazole leads to QT prolongation in healthy volunteers: a randomized, placebo-controlled, double-blind, crossover study.
    British journal of clinical pharmacology, 2012, Volume: 73, Issue:3

    Topics: 14-alpha Demethylase Inhibitors; Adolescent; Adult; Analysis of Variance; Area Under Curve; Arrhythm

2012
A thorough QTc study of 3 doses of iloperidone including metabolic inhibition via CYP2D6 and/or CYP3A4 and a comparison to quetiapine and ziprasidone.
    Journal of clinical psychopharmacology, 2013, Volume: 33, Issue:1

    Topics: Adolescent; Adult; Aged; Antipsychotic Agents; Cytochrome P-450 CYP2D6; Cytochrome P-450 CYP2D6 Inhi

2013
Man versus machine: is there an optimal method for QT measurements in thorough QT studies?
    Journal of clinical pharmacology, 2006, Volume: 46, Issue:6

    Topics: Adolescent; Adult; Aza Compounds; Control Groups; Cross-Over Studies; Electrocardiography; Female; F

2006
The prokinetic cinitapride has no clinically relevant pharmacokinetic interaction and effect on QT during coadministration with ketoconazole.
    Drug metabolism and disposition: the biological fate of chemicals, 2007, Volume: 35, Issue:7

    Topics: Administration, Oral; Adult; Area Under Curve; Aryl Hydrocarbon Hydroxylases; Benzamides; Biological

2007
Ritonavir 100 mg does not cause QTc prolongation in healthy subjects: a possible role as CYP3A inhibitor in thorough QTc studies.
    Clinical pharmacology and therapeutics, 2008, Volume: 83, Issue:1

    Topics: Adult; Aza Compounds; Cross-Over Studies; Cytochrome P-450 CYP3A; Cytochrome P-450 Enzyme Inhibitors

2008

Other Studies

9 other studies available for ketoconazole and Long QT Syndrome

ArticleYear
Use of rifabutin for the treatment of a latent tuberculosis infection in a patient after solid organ transplantation.
    Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, 2013, Volume: 19, Issue:4

    Topics: Adolescent; Antibiotics, Antitubercular; Drug Interactions; Drug Monitoring; Drug Substitution; Drug

2013
No Untoward Effect of Long-Term Ketoconazole Administration on Electrocardiographic QT Interval in Patients with Cushing's Disease.
    Basic & clinical pharmacology & toxicology, 2016, Volume: 118, Issue:4

    Topics: Adrenocorticotropic Hormone; Adult; Dose-Response Relationship, Drug; Electrocardiography; Female; H

2016
Inhibition of hERG channel trafficking: an under-explored mechanism for drug-induced QT prolongation.
    ChemMedChem, 2008, Volume: 3, Issue:10

    Topics: ERG1 Potassium Channel; Ether-A-Go-Go Potassium Channels; Fluoxetine; Humans; Inhibitory Concentrati

2008
QT and RR intervals in conscious and anesthetized guinea pigs with highly varying RR intervals and given QTc-lengthening test articles.
    Toxicological sciences : an official journal of the Society of Toxicology, 2003, Volume: 76, Issue:2

    Topics: Anesthesia; Animals; Anti-Arrhythmia Agents; Arrhythmias, Cardiac; Cisapride; Consciousness; Electro

2003
Ketoconazole induced torsades de pointes without concomitant use of QT interval-prolonging drug.
    Journal of cardiovascular electrophysiology, 2005, Volume: 16, Issue:12

    Topics: Antifungal Agents; Coronary Artery Disease; Female; Humans; Ketoconazole; Long QT Syndrome; Middle A

2005
Disopyramide: although potentially life-threatening in the setting of long QT, could it be life-saving in short QT syndrome?
    Journal of molecular and cellular cardiology, 2006, Volume: 41, Issue:3

    Topics: Anti-Arrhythmia Agents; Arrhythmias, Cardiac; Death, Sudden, Cardiac; Disopyramide; Drug Interaction

2006
Interaction between ketoconazole and domperidone and the risk of QT prolongation--important safety information.
    South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 2006, Volume: 96, Issue:7

    Topics: Antiemetics; Antifungal Agents; Domperidone; Drug Interactions; Humans; Ketoconazole; Long QT Syndro

2006
Coexistence of hERG current block and disruption of protein trafficking in ketoconazole-induced long QT syndrome.
    British journal of pharmacology, 2008, Volume: 153, Issue:3

    Topics: Antifungal Agents; Binding Sites; Blotting, Western; Cell Line; Dose-Response Relationship, Drug; El

2008
Torsades de Pointes after treatment with terfenadine and ketoconazole.
    European heart journal, 1992, Volume: 13, Issue:7

    Topics: Adult; Cardiac Pacing, Artificial; Dermatomycoses; Drug Therapy, Combination; Electrocardiography, A

1992