CLINICAL TRIALS PROFILE FOR PRETOMANID
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All Clinical Trials for pretomanid
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00042289 ↗ | Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | 2003-03-01 | The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions. | |
| NCT00042289 ↗ | Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 2003-03-01 | The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions. | |
| NCT02256696 ↗ | Assessing PA-824 for Tuberculosis (the APT Trial) | Recruiting | University of Cape Town | Phase 2 | 2015-04-29 | Assess the mycobactericidal activity of PA-824 (given at 200 mg daily) when added to first-line tuberculosis (TB) treatment (isoniazid, pyrazinamide, and a rifamycin antibiotic) over 12 weeks of treatment. Funding Source - FDA OOPD |
| NCT02256696 ↗ | Assessing PA-824 for Tuberculosis (the APT Trial) | Recruiting | Johns Hopkins University | Phase 2 | 2015-04-29 | Assess the mycobactericidal activity of PA-824 (given at 200 mg daily) when added to first-line tuberculosis (TB) treatment (isoniazid, pyrazinamide, and a rifamycin antibiotic) over 12 weeks of treatment. Funding Source - FDA OOPD |
| NCT02333799 ↗ | A Phase 3 Study Assessing the Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Subjects With Drug Resistant Pulmonary Tuberculosis | Completed | Global Alliance for TB Drug Development | Phase 3 | 2015-03-01 | The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment (option for 9 months for subjects who remain culture positive at month 4) in Subjects with either pulmonary extensively drug resistant tuberculosis (XDR-TB), treatment intolerant or non-responsive multi-drug resistant tuberculosis (MDR-TB). |
| NCT02422524 ↗ | Pretomanid in Adults With Hepatic Impairment | Recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 | 2017-12-11 | This is a Phase 1, single dose (200 mg), open-label, sequential group study comparing the pharmacokinetics and safety of Pretomanid in subjects with mild, moderate, and severe hepatic impairment to matched, non-hepatically impaired subjects. There will be approximately 36 total subjects, adult males and females, 18 to 70 years of age, inclusive. The study will be conducted at 2 sites, study duration is approximately 24 months, and subject participation duration is approximately 5 weeks (including screening). Primary objective: To evaluate the pharmacokinetics of a single oral dose of Pretomanid in subjects with mild, moderate, and severe hepatic impairment (as assessed by Child-Pugh score), relative to matched non-hepatically impaired subjects. Secondary objective: To evaluate the safety of a single oral dose of Pretomanid in subjects with mild, moderate, and severe hepatic impairment (as assessed by Child-Pugh score), relative to matched non-hepatically impaired subjects. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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