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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 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 8 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03931590
The ClinicalTrials.gov registry entry for NCT03931590 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 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 [14C]-Omaveloxolone is the first listed.
NCT03931590 reports 0 study locations.
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.
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