Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01768273 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Pharmacokinetic Interaction Between PA-824 and Midazolam
A Phase 1 study, sponsored by Global Alliance for TB Drug Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01768273: Completed Phase 1 study, sponsored by Global Alliance for TB Drug Development.
NCT01768273 is a Phase 1 study that has completed, run by Global Alliance for TB Drug Development. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01768273, a Phase 1 study, has completed, sponsored by Global Alliance for TB Drug Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and tolerability of PA-824 when given with a single dose of midazolam, and to determine whether PA-824 inhibits CYP3A to a clinically important degree as measured by the effect of PA-824 on the pharmacokinetics of midazolam, a known CYP3A substrate.
Primary Outcome
The PK parameters to be calculated for midazolam and 1-hydroxy midazolam include area under the curve \[AUC(0-t) and AUC(0-inf)\], maximum observed concentration (Cmax), time to maximum observed plasma concentration (Tmax), half-life (t1/2), and apparent terminal elimination rate constant (Kel).
Interventions
- DRUG Midazolam
- DRUG PA-824
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-04 |
| Phase | Phase 1 |
What the finished NCT01768273 record still lists
NCT01768273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT01768273 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01768273 about?
NCT01768273 is a clinical study titled "Evaluation of the Pharmacokinetic Interaction Between PA-824 and Midazolam". The purpose of this study is to determine the safety and tolerability of PA-824 when given with a single dose of midazolam, and to determine whether PA-824 inhibits CYP3A to a clinically important degree as measured by the effect of PA-824 on the pharmacokinetics of midazolam, a known CYP3A substrat...
What is the current status of trial NCT01768273?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2009-12. Estimated completion is 2010-04.
What interventions are being tested in trial NCT01768273?
The interventions under investigation include: Midazolam (DRUG), PA-824 (DRUG).
Who is sponsoring clinical trial NCT01768273?
This trial is sponsored by Global Alliance for TB Drug Development, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01768273's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02523092 · 14 participants · Phase 4
Use of CXCL9 as a Biomarker of Acthar Efficacy
- NCT04263285 · 14 participants · NA
Treatment of Depression Post-SCI
- NCT04743271 · 14 participants · NA
Food and Circadian Timing
- NCT05065671 · 14 participants · Phase 1
Microbiome Derived Metabolism and Pharmacokinetics
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia