Trials / Completed
CompletedNCT05927649
A TQTc Study for Omaveloxolone
A Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Way Crossover Study in Healthy Subjects to Determine the Effect of Omaveloxolone on QTc Interval
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omaveloxolone | Omaveloxolone capsules |
| DRUG | Moxifloxacin | Moxifloxacin capsules |
Timeline
- Start date
- 2023-07-11
- Primary completion
- 2023-09-01
- Completion
- 2023-09-01
- First posted
- 2023-07-03
- Last updated
- 2025-05-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05927649. Inclusion in this directory is not an endorsement.