| pretomanid (PA-824) / Global Alliance for TB Drug Development |
CL-004, NCT03202693: A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects. |
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| Completed | 1 | 6 | US | PA-824 | Global Alliance for TB Drug Development | Tuberculosis | 05/06 | 05/06 | | |
CL-003, NCT01828827: Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects |
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| Completed | 1 | 16 | US | PA-824 1000 mg | Global Alliance for TB Drug Development | Tuberculosis | 03/07 | 03/07 | | |
CL-009, NCT01830439: Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects |
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| Completed | 1 | 32 | US | PA-824 200mg, PA-824 50mg | Global Alliance for TB Drug Development | Tuberculosis | 01/10 | 01/10 | | |
NCT01768273: Evaluation of the Pharmacokinetic Interaction Between PA-824 and Midazolam |
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| Completed | 1 | 14 | US | Midazolam, Dormicum, Hypnovel, Versed, PA-824 | Global Alliance for TB Drug Development | Tuberculosis | 01/10 | 04/10 | | |
NCT01674218: Effect of PA-824 and of PA-824 Plus Moxifloxacin on the QTc Interval in Healthy Volunteers |
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| Completed | 1 | 74 | US | Moxifloxacin, PA-824, Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Tuberculosis | 12/12 | 12/12 | | |
NCT01571414: Evaluating the Safety and Drug Interaction of PA-824, an Investigational Tuberculosis Medication, Together With Efavirenz, Ritonavir-Boosted Lopinavir, or Rifampin |
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| Completed | 1 | 52 | US | PA-824, Efavirenz (EFV), Lopinavir/Ritonavir (LPV/r), Rifampin (RIF) | National Institute of Allergy and Infectious Diseases (NIAID) | Tuberculosis | 05/13 | 05/13 | | |
NCT04309656: Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid |
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| Completed | 1 | 48 | US | Pretomanid, PA-824 | Global Alliance for TB Drug Development | Multi-drug Resistant Tuberculosis | 02/20 | 02/20 | | |
| Recruiting | 1 | 16 | | 8 subjects in group 1 take a single dose of 200mg under fasted state on Day1 and 200mg after a high-fat meal on Day10; 8 subjects in group 2 take a single dose of 200mg after a high-fat meal on Day1 and 200mg under fasted state on Day10 | Peking University Third Hospital; Shenyang Hongqi Pharmaceutical Co., Ltd, Own funds | Tuberculosis | | | | |
NCT03896750: Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function |
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| Recruiting | 1 | 36 | US | PA-824 | National Institute of Allergy and Infectious Diseases (NIAID) | Renal Impairment, Tuberculosis | 01/25 | 07/25 | | |
| Terminated | 1 | 14 | US | PA-824 | National Institute of Allergy and Infectious Diseases (NIAID) | Tuberculosis | 08/23 | 11/23 | | |
NCT05586230: Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis |
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| Recruiting | 1 | 72 | RoW | Pretomanid, Pa, Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB | National Institute of Allergy and Infectious Diseases (NIAID), Global Alliance for TB Drug Development, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH) | Tuberculosis, Rifampicin Resistant Tuberculosis | 01/26 | 01/26 | | |
