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NCT04309656 · ClinicalTrials.gov registry record · Phase 1
Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid
A Phase 1 study of Multi-drug Resistant Tuberculosis, sponsored by Global Alliance for TB Drug Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT04309656: Completed Phase 1 study of Multi-drug Resistant Tuberculosis, sponsored by Global Alliance for TB Drug Development.
NCT04309656 is a Phase 1 study of Multi-drug Resistant Tuberculosis that has completed, run by Global Alliance for TB Drug Development. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04309656, a Phase 1 study of Multi-drug Resistant Tuberculosis, has completed, sponsored by Global Alliance for TB Drug Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.
Primary Outcome
Relative bioavailability will be determined separately for each panel using Cmax
Conditions Studied
Interventions
- DRUG Pretomanid
Study Locations (1)
Texas
- Worldwide Clinical Trials Early Phase Services, LLC - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-01-14 |
| Est. Completion | 2020-02-28 |
| Phase | Phase 1 |
What the finished NCT04309656 record still lists
NCT04309656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Multi-drug Resistant Tuberculosis appearing as the primary indexed condition, and to 1 intervention - of which Pretomanid is the first listed.
NCT04309656 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04309656 about?
NCT04309656 is a clinical study titled "Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid". This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.
What is the current status of trial NCT04309656?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2020-01-14. Estimated completion is 2020-02-28.
What conditions does trial NCT04309656 study?
This clinical trial studies the following conditions: Multi-drug Resistant Tuberculosis.
What interventions are being tested in trial NCT04309656?
The interventions under investigation include: Pretomanid (DRUG).
Who is sponsoring clinical trial NCT04309656?
This trial is sponsored by Global Alliance for TB Drug Development, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04309656 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04309656's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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
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