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NCT05927649 · ClinicalTrials.gov registry record · Phase 1
A TQTc Study for Omaveloxolone
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT05927649: Completed Phase 1 study, sponsored by Biogen.
NCT05927649 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05927649, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a randomized, double blind, placebo and active (moxifloxacin open label) controlled study in healthy subjects to assess the effect of the supratherapeutic exposure of omaveloxolone on QTc interval. Moxifloxacin will be used as an active control and will be administered as open label. Omaveloxolone and placebo will be administered in a blinded fashion. All treatments will be administered after an FDA high-fat meal. Concentration-QTc (C-QTc) analysis is the primary analysis for the study.
Primary Outcome
The relationship between ∆QTcF and omaveloxolone and its metabolites, M17 and M22 plasma concentrations will be investigated by a linear mixed effects modeling approach with ∆ QTcF as the dependent variable, time-matched concentration of omaveloxolone and its metabolites as a continuous covariate (ie, 0 for placebo), and centered baseline QTcF as an additional covariate, treatment (active = 1; or placebo = 0) and time as categorical factors, and a random intercept and slope per subject.
Interventions
- DRUG Moxifloxacin
- DRUG Omaveloxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-07-11 |
| Est. Completion | 2023-09-01 |
| Phase | Phase 1 |
What the finished NCT05927649 record still lists
NCT05927649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Moxifloxacin is the first listed.
NCT05927649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05927649 about?
NCT05927649 is a clinical study titled "A TQTc Study for Omaveloxolone". This is a randomized, double blind, placebo and active (moxifloxacin open label) controlled study in healthy subjects to assess the effect of the supratherapeutic exposure of omaveloxolone on QTc interval. Moxifloxacin will be used as an active control and will be administered as open label. Omavelo...
What is the current status of trial NCT05927649?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-07-11. Estimated completion is 2023-09-01.
What interventions are being tested in trial NCT05927649?
The interventions under investigation include: Moxifloxacin (DRUG), Omaveloxolone (DRUG).
Who is sponsoring clinical trial NCT05927649?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05927649's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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