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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 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
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03199313
The ClinicalTrials.gov registry entry for NCT03199313 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 2 interventions - of which Placebo is the first listed.
NCT03199313 reports 0 study locations.
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.
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