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Last Updated: December 15, 2019

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CLINICAL TRIALS PROFILE FOR PA-824

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Clinical Trials for Pa-824

Trial ID Title Status Sponsor Phase Summary
NCT00567840 PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis Completed Global Alliance for TB Drug Development Phase 2 The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard TB treatment.
NCT00944021 Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010) Completed Global Alliance for TB Drug Development Phase 2 The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 50, 100, 150 and 200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis (TB). A control group will receive standard TB treatment.
NCT01215851 Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001) Completed Global Alliance for TB Drug Development Phase 2 The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with pyrazinamide and PA-824 with moxifloxacin and pyrazinamide, as determined by the rate of change of log CFU in sputum over the time period Day 0-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.
NCT01498419 Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002) Completed Global Alliance for TB Drug Development Phase 2 The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin plus PA-824 plus pyrazinamide regimen after 8 weeks of treatment.
NCT01571414 Evaluating the Safety and Drug Interaction of PA-824, an Investigational Tuberculosis Medication, Together With Efavirenz, Ritonavir-Boosted Lopinavir, or Rifampin Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 Tuberculosis (TB) is a global public health concern and developing new treatment regimens is an important research priority. PA-824 is an experimental TB medication. This study will evaluate the safety and tolerability of PA-824 when combined with efavirenz (EFV) or ritonavir-boosted lopinavir (LPV/r), which are medications used to treat HIV infection, or rifampin (RIF), which is a medication used to treat TB. Study researchers will examine the safety and tolerability of these drug combinations and how the medications affect the levels of PA-824 in the blood.
NCT01674218 Effect of PA-824 and of PA-824 Plus Moxifloxacin on the QTc Interval in Healthy Volunteers Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 This is a Phase I, single-center, double-blinded, randomized, placebo-controlled, five-period cross-over clinical study of PA-824 to evaluate the effect of PA-824 and of PA-824 plus moxifloxacin on cardiac repolarization (QT/QTc interval duration) in a total of 75 healthy male and female participants, aged 18 to 45 years. Moxifloxacin will be used as an active control. Participants will be blinded to the treatments they will receive. The study consists of a screening period up to 26 days; enrollment, 1 day; five in-patient treatment periods consisting of an admission day (except in the first treatment period, when the pre-dose day is the baseline), dosing day and two post-dosing days; an out-patient period of at least three days and not more than 10 days between treatment periods; and a final visit 7 - 14 days after discharge from the last treatment period.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Pa-824

Condition Name

Condition Name for
Intervention Trials
Tuberculosis 11
Pulmonary Tuberculosis 8
Tuberculosis, Pulmonary 4
Tuberculosis, Multidrug-Resistant 4
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Condition MeSH

Condition MeSH for
Intervention Trials
Tuberculosis 22
Tuberculosis, Pulmonary 14
Tuberculosis, Multidrug-Resistant 7
Extensively Drug-Resistant Tuberculosis 5
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Clinical Trial Locations for Pa-824

Trials by Country

Trials by Country for
Location Trials
South Africa 27
United States 10
Tanzania 3
Malaysia 3
Uzbekistan 2
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Trials by US State

Trials by US State for
Location Trials
Nebraska 3
Wisconsin 1
North Carolina 1
Kansas 1
Tennessee 1
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Clinical Trial Progress for Pa-824

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 3
Phase 2/Phase 3 3
Phase 2 8
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 11
Not yet recruiting 5
Recruiting 2
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Clinical Trial Sponsors for Pa-824

Sponsor Name

Sponsor Name for
Sponsor Trials
Global Alliance for TB Drug Development 17
National Institute of Allergy and Infectious Diseases (NIAID) 3
London School of Hygiene and Tropical Medicine 3
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Sponsor Type

Sponsor Type for
Sponsor Trials
Other 51
NIH 3
Industry 2
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