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NCT03902002 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT03902002: Completed Phase 1 study, sponsored by Biogen.
NCT03902002 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03902002, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This study will examine the pharmacokinetics (PK) of omaveloxolone following a single oral dose of omaveloxolone in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function.
Primary Outcome
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Interventions
- DRUG Omaveloxolone 50 mg capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-07-19 |
| Est. Completion | 2020-01-27 |
| Phase | Phase 1 |
What the finished NCT03902002 record still lists
NCT03902002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 1 intervention - of which Omaveloxolone 50 mg capsules is the first listed.
NCT03902002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03902002 about?
NCT03902002 is a clinical study titled "A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function". This study will examine the pharmacokinetics (PK) of omaveloxolone following a single oral dose of omaveloxolone in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function.
What is the current status of trial NCT03902002?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2019-07-19. Estimated completion is 2020-01-27.
What interventions are being tested in trial NCT03902002?
The interventions under investigation include: Omaveloxolone 50 mg capsules (DRUG).
Who is sponsoring clinical trial NCT03902002?
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 NCT03902002's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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