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NCT05909644 · ClinicalTrials.gov registry record · Phase 1
An Open-label DDI Study of Omaveloxolone in Healthy Subjects
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT05909644: Completed Phase 1 study, sponsored by Biogen.
NCT05909644 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05909644, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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).
Primary Outcome
Blood samples to assess omaveloxolone PK will be collected predose and at the specified time points over a 336-hour period following each omaveloxolone dose for the duration of the study.
Interventions
- DRUG Omaveloxolone
- DRUG Efavirenz
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-07-05 |
| Est. Completion | 2023-08-30 |
| Phase | Phase 1 |
What the finished NCT05909644 record still lists
NCT05909644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Omaveloxolone is the first listed.
NCT05909644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05909644 about?
NCT05909644 is a clinical study titled "An Open-label DDI Study of Omaveloxolone in Healthy Subjects". 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...
What is the current status of trial NCT05909644?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-07-05. Estimated completion is 2023-08-30.
What interventions are being tested in trial NCT05909644?
The interventions under investigation include: Omaveloxolone (DRUG), Efavirenz (DRUG).
Who is sponsoring clinical trial NCT05909644?
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 NCT05909644's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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