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NCT02216331 · ClinicalTrials.gov registry record · Phase 1
PK Interaction Between Rifapentine or Rifampicin and a Single Dose of TMC207 in Healthy Subjects (TMC207-CL002)
A Phase 1 study, sponsored by Global Alliance for TB Drug Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT02216331 is a Phase 1 study that has completed, run by Global Alliance for TB Drug Development. The registered enrollment target is 32 participants.
The verdict
NCT02216331, a Phase 1 study, has completed, sponsored by Global Alliance for TB Drug Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This is a open-label study, 2-treatment, 2-period, single sequence design. Period 1 will examine the pharmacokinetics of TMC207 in the absence of rifapentine or rifampicin. Subjects will receive a single 400-mg dose of TMC207 administered alone on Study Day 1. Period 2 will examine the effects of repeated doses of either rifapentine or rifampicin on TMC207 pharmacokinetics and will begin on Study Day 20. During Period 2, subjects will receive 22 daily doses of either 600 mg rifapentine or rifampicin from Study Day 20 through Study Day 41. A single 400-mg dose of TMC207 will be administered on Study Day 29. Subjects will be confined to the clinic from Study Day-1 to Study Day 2 in the morning of Period 1, and Study Day 19 to Study Day 30 in the morning of Period 2. The study hypothesis is to determine whether Rifapentine affects the pharmacokinetics of TMC207 as measured by effects on Cmax and AUC(0-t) to a lesser degree than rifampicin.
Interventions
- DRUG TMC207
- DRUG rifapentine
- DRUG rifampicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02216331
The ClinicalTrials.gov registry entry for NCT02216331 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 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 3 interventions - of which TMC207 is the first listed.
NCT02216331 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02216331 about?
NCT02216331 is a clinical study titled "PK Interaction Between Rifapentine or Rifampicin and a Single Dose of TMC207 in Healthy Subjects (TMC207-CL002)". This is a open-label study, 2-treatment, 2-period, single sequence design. Period 1 will examine the pharmacokinetics of TMC207 in the absence of rifapentine or rifampicin. Subjects will receive a single 400-mg dose of TMC207 administered alone on Study Day 1. Period 2 will examine the effects of re...
What is the current status of trial NCT02216331?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2010-03. Estimated completion is 2010-05.
What interventions are being tested in trial NCT02216331?
The interventions under investigation include: TMC207 (DRUG), rifapentine (DRUG), rifampicin (DRUG).
Who is sponsoring clinical trial NCT02216331?
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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