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NCT03199313 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
A Phase 1 study, sponsored by Global Alliance for TB Drug Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT03199313: Completed Phase 1 study, sponsored by Global Alliance for TB Drug Development.
NCT03199313 is a Phase 1 study that has completed, run by Global Alliance for TB Drug Development. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03199313, 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 randomized, double-blind, placebo-controlled, single ascending dose study conducted at one study center in the United States. Four (4) cohorts of 8 subjects each (6 active and 2 placebo). Subjects will participate in only one cohort. Safety will be assessed throughout the study; serial ECGs and serial blood samples will be collected for the safety and PK assessment of sutezolid. Dose escalation to the next cohort (i.e., dose level) will not take place until the Sponsor, in conjunction with the Principal Investigator, has determined that adequate safety, tolerability and PK from the previous cohort has been demonstrated to permit proceeding to the next cohort. Interim PK analyses will be performed for the dose escalation decisions to reconsider the sampling time points as the study progresses. All samples will be sent for analysis and the bioanalytical lab will be unblinded and only run the analysis on active treatment subjects. Data from the analysis used for the escalation meetings will only include active treatment subjects, and will be blinded by subject. Subjects will be housed in the clinic from at least 24 hours prior (from Day -2), until 48 hours (Day 3) after dosing. Subjects will be contacted via a phone call for follow-up questioning about adverse events 7 days later (Study Day 10).
Primary Outcome
Safety will be evaluated by Treatment Emergent Adverse Events (TEAEs) following doses of sutezolid or placebo
Interventions
- DRUG Placebo
- DRUG Sutezolid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-09-26 |
| Est. Completion | 2017-12-16 |
| Phase | Phase 1 |
What the finished NCT03199313 record still lists
NCT03199313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03199313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03199313 about?
NCT03199313 is a clinical study titled "Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid". This is a randomized, double-blind, placebo-controlled, single ascending dose study conducted at one study center in the United States. Four (4) cohorts of 8 subjects each (6 active and 2 placebo). Subjects will participate in only one cohort. Safety will be assessed throughout the study; serial EC...
What is the current status of trial NCT03199313?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2017-09-26. Estimated completion is 2017-12-16.
What interventions are being tested in trial NCT03199313?
The interventions under investigation include: Placebo (DRUG), Sutezolid (DRUG).
Who is sponsoring clinical trial NCT03199313?
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 NCT03199313's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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