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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 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 20 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05909644
The ClinicalTrials.gov registry entry for NCT05909644 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Omaveloxolone is the first listed.
NCT05909644 reports 0 study locations.
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.
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