drugset / Trial / NCT05909644
An Open-label DDI Study of Omaveloxolone in Healthy Subjects
Phase 1
Completed
20 enrolled
Biogen
Altasciences Company Inc. · collabCelerion · collabQ2 Solutions · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2023-07-05
- Primary completion
- 2023-08-30
- Completion
- 2023-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efavirenz | Other / unclassified | 600 mg | Oral |
| Subject | Omaveloxolone | Small molecule | 150 mg | Oral |
Indications
No indication recorded.