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NCT01563562 · ClinicalTrials.gov registry record · Phase 1
Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01563562: Completed Phase 1 study, sponsored by Biogen.
NCT01563562 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01563562, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and severe hepatic impairment, as compared to healthy volunteers.
Interventions
- DRUG Bardoxolone Methyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-04-30 |
| Est. Completion | 2012-11-30 |
| Phase | Phase 1 |
What the finished NCT01563562 record still lists
NCT01563562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which Bardoxolone Methyl is the first listed.
NCT01563562 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01563562 about?
NCT01563562 is a clinical study titled "Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function". The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and severe hepatic impairment, as compared to healthy volunteers.
What is the current status of trial NCT01563562?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2012-04-30. Estimated completion is 2012-11-30.
What interventions are being tested in trial NCT01563562?
The interventions under investigation include: Bardoxolone Methyl (DRUG).
Who is sponsoring clinical trial NCT01563562?
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 NCT01563562's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 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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