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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 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 48 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03902002
The ClinicalTrials.gov registry entry for NCT03902002 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 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 1 intervention - of which Omaveloxolone 50 mg capsules is the first listed.
NCT03902002 reports 0 study locations.
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.
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