Trials / Completed
CompletedNCT05909644
An Open-label DDI Study of Omaveloxolone in Healthy Subjects
A Single Sequence, 2-Period, Open-label Crossover Study in Healthy Subjects to Determine the Effect of a Moderate CYP3A4 Inducer on the Pharmacokinetics of Omaveloxolone
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is an open-label, single-sequence, 2-period crossover study in healthy subjects. In this study, 20 subjects will be enrolled to allow at least 16 evaluable subjects. Subjects will receive a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) on Day 1 (Period 1) and on Day 29 (Period 2), and 600 mg efavirenz once a day from Days 15 through 42 (Period 2).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omaveloxolone | Omaveloxolone Capsules, 150 mg, administered orally |
| DRUG | Efavirenz | Efavirenz Tablet, 600 mg, administered orally once daily |
Timeline
- Start date
- 2023-07-05
- Primary completion
- 2023-08-30
- Completion
- 2023-08-30
- First posted
- 2023-06-18
- Last updated
- 2025-05-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05909644. Inclusion in this directory is not an endorsement.