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NCT04008186 · ClinicalTrials.gov registry record · Phase 1
A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT04008186: Completed Phase 1 study, sponsored by Biogen.
NCT04008186 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04008186, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
This study will assess the potential for clinical drug-drug interactions between omaveloxolone and a number of substrates and inhibitors of metabolic enzymes and drug transporters.
Primary Outcome
Pharmacokinetics will be assessed by blood sampling for midazolam, repaglinide, metformin, rosuvastatin, and digoxin to determine maximum observed concentration (Cmax).
Interventions
- DRUG Omaveloxolone
- DRUG Rosuvastatin
- DRUG Midazolam oral solution
- DRUG Repaglinide 1 MG
- DRUG MetFORMIN 500 Mg Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2019-06-14 |
| Est. Completion | 2019-08-28 |
| Phase | Phase 1 |
What the finished NCT04008186 record still lists
NCT04008186 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Omaveloxolone is the first listed.
NCT04008186 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04008186 about?
NCT04008186 is a clinical study titled "A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone". This study will assess the potential for clinical drug-drug interactions between omaveloxolone and a number of substrates and inhibitors of metabolic enzymes and drug transporters.
What is the current status of trial NCT04008186?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2019-06-14. Estimated completion is 2019-08-28.
What interventions are being tested in trial NCT04008186?
The interventions under investigation include: Omaveloxolone (DRUG), Rosuvastatin (DRUG), Midazolam oral solution (DRUG), Repaglinide 1 MG (DRUG), MetFORMIN 500 Mg Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT04008186?
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 NCT04008186's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 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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