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NCT05927649 · ClinicalTrials.gov registry record · Phase 1
A TQTc Study for Omaveloxolone
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT05927649 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 30 participants.
The verdict
NCT05927649, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a randomized, double blind, placebo and active (moxifloxacin open label) controlled study in healthy subjects to assess the effect of the supratherapeutic exposure of omaveloxolone on QTc interval. Moxifloxacin will be used as an active control and will be administered as open label. Omaveloxolone and placebo will be administered in a blinded fashion. All treatments will be administered after an FDA high-fat meal. Concentration-QTc (C-QTc) analysis is the primary analysis for the study.
Interventions
- DRUG Moxifloxacin
- DRUG Omaveloxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-07-11 |
| Est. Completion | 2023-09-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05927649
The ClinicalTrials.gov registry entry for NCT05927649 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 2 interventions - of which Moxifloxacin is the first listed.
NCT05927649 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05927649 about?
NCT05927649 is a clinical study titled "A TQTc Study for Omaveloxolone". This is a randomized, double blind, placebo and active (moxifloxacin open label) controlled study in healthy subjects to assess the effect of the supratherapeutic exposure of omaveloxolone on QTc interval. Moxifloxacin will be used as an active control and will be administered as open label. Omavelo...
What is the current status of trial NCT05927649?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-07-11. Estimated completion is 2023-09-01.
What interventions are being tested in trial NCT05927649?
The interventions under investigation include: Moxifloxacin (DRUG), Omaveloxolone (DRUG).
Who is sponsoring clinical trial NCT05927649?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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