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NCT03202693 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects.
A Phase 1 study, sponsored by Global Alliance for TB Drug Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03202693 is a Phase 1 study that has completed, run by Global Alliance for TB Drug Development. The registered enrollment target is 6 participants.
The verdict
NCT03202693, a Phase 1 study, has completed, sponsored by Global Alliance for TB Drug Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This study is a Phase 1, single-center, open-label, single-dose study to evaluate (1) the absorption, metabolism, and excretion patterns of a single dose of \[14C\] PA-824, and (2) the pharmacokinetics, safety, and tolerability of a single oral-suspension dose of unlabeled PA-824 in healthy adult male subjects. Unlabeled PA-824 and \[14C\]-PA-824 will be administered together in an oral-suspension formulation. Enrollment is planned for one dose group of 6 subjects. All 6 subjects will receive the same treatment.
Interventions
- DRUG PA-824
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2006-03 |
| Est. Completion | 2006-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03202693
The ClinicalTrials.gov registry entry for NCT03202693 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Global Alliance for TB Drug Development, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PA-824 is the first listed.
NCT03202693 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03202693 about?
NCT03202693 is a clinical study titled "A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects.". This study is a Phase 1, single-center, open-label, single-dose study to evaluate (1) the absorption, metabolism, and excretion patterns of a single dose of \[14C\] PA-824, and (2) the pharmacokinetics, safety, and tolerability of a single oral-suspension dose of unlabeled PA-824 in healthy adult ma...
What is the current status of trial NCT03202693?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2006-03. Estimated completion is 2006-05.
What interventions are being tested in trial NCT03202693?
The interventions under investigation include: PA-824 (DRUG).
Who is sponsoring clinical trial NCT03202693?
This trial is sponsored by Global Alliance for TB Drug Development, which has 13 total clinical trials registered on ClinicalTrials.gov.
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