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NCT03931590 · ClinicalTrials.gov registry record · Phase 1
A Human AME Study for Omaveloxolone
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT03931590: Completed Phase 1 study, sponsored by Biogen.
NCT03931590 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03931590, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study will assess the pharmacokinetics (PK), mass balance, metabolite profiles, and rates and routes of elimination of \[14C\] omaveloxolone and derived metabolites following administration as a single 150 mg (containing approximately 90 µCi) dose to healthy male subjects.
Primary Outcome
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Interventions
- DRUG [14C]-Omaveloxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-04-11 |
| Est. Completion | 2019-05-31 |
| Phase | Phase 1 |
What the finished NCT03931590 record still lists
NCT03931590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which [14C]-Omaveloxolone is the first listed.
NCT03931590 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03931590 about?
NCT03931590 is a clinical study titled "A Human AME Study for Omaveloxolone". This study will assess the pharmacokinetics (PK), mass balance, metabolite profiles, and rates and routes of elimination of \[14C\] omaveloxolone and derived metabolites following administration as a single 150 mg (containing approximately 90 µCi) dose to healthy male subjects.
What is the current status of trial NCT03931590?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2019-04-11. Estimated completion is 2019-05-31.
What interventions are being tested in trial NCT03931590?
The interventions under investigation include: [14C]-Omaveloxolone (DRUG).
Who is sponsoring clinical trial NCT03931590?
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 NCT03931590's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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