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NCT01461161 · ClinicalTrials.gov registry record · Phase 1
A Single-Dose, Open-Label, Randomized, Food Effect and Blinded, Randomized, Dose Proportionality Study in Healthy Volunteers With Bardoxolone Methyl
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01461161: Completed Phase 1 study, sponsored by Biogen.
NCT01461161 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01461161, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study is to determine the effect of food on a single dose of 20 mg bardoxolone methyl administered to normal healthy adult subjects.
Interventions
- DRUG bardoxolone methyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-10-31 |
| Est. Completion | 2011-12-31 |
| Phase | Phase 1 |
What the finished NCT01461161 record still lists
NCT01461161 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which bardoxolone methyl is the first listed.
NCT01461161 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01461161 about?
NCT01461161 is a clinical study titled "A Single-Dose, Open-Label, Randomized, Food Effect and Blinded, Randomized, Dose Proportionality Study in Healthy Volunteers With Bardoxolone Methyl". This study is to determine the effect of food on a single dose of 20 mg bardoxolone methyl administered to normal healthy adult subjects.
What is the current status of trial NCT01461161?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2011-10-31. Estimated completion is 2011-12-31.
What interventions are being tested in trial NCT01461161?
The interventions under investigation include: bardoxolone methyl (DRUG).
Who is sponsoring clinical trial NCT01461161?
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 NCT01461161's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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