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NCT03664453 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT03664453: Completed Phase 1 study, sponsored by Biogen.
NCT03664453 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03664453, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg omaveloxolone in healthy adult subjects. The study will be conducted in two parts, conducted simultaneously. Part 1 will assess the food effect, while Part 2 will assess dose proportionality.
Primary Outcome
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Interventions
- DRUG omaveloxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-10-29 |
| Est. Completion | 2018-11-20 |
| Phase | Phase 1 |
What the finished NCT03664453 record still lists
NCT03664453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which omaveloxolone is the first listed.
NCT03664453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03664453 about?
NCT03664453 is a clinical study titled "A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers". This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg omaveloxolone in healthy adult subjects. The study will be conducted in two parts,...
What is the current status of trial NCT03664453?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2018-10-29. Estimated completion is 2018-11-20.
What interventions are being tested in trial NCT03664453?
The interventions under investigation include: omaveloxolone (DRUG).
Who is sponsoring clinical trial NCT03664453?
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 NCT03664453's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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