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NCT03664453 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT03664453 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 32 participants.
The verdict
NCT03664453, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg omaveloxolone in healthy adult subjects. The study will be conducted in two parts, conducted simultaneously. Part 1 will assess the food effect, while Part 2 will assess dose proportionality.
Interventions
- DRUG omaveloxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-10-29 |
| Est. Completion | 2018-11-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03664453
The ClinicalTrials.gov registry entry for NCT03664453 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 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 is the first listed.
NCT03664453 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03664453 about?
NCT03664453 is a clinical study titled "A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers". This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg omaveloxolone in healthy adult subjects. The study will be conducted in two parts,...
What is the current status of trial NCT03664453?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2018-10-29. Estimated completion is 2018-11-20.
What interventions are being tested in trial NCT03664453?
The interventions under investigation include: omaveloxolone (DRUG).
Who is sponsoring clinical trial NCT03664453?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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