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NCT01598363 · ClinicalTrials.gov registry record · Phase 1
An Open-Label Study of the Effect of Bardoxolone Methyl on the Single Dose Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Volunteers
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01598363: Completed Phase 1 study, sponsored by Biogen.
NCT01598363 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
NCT01598363, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the potential effect of bardoxolone methyl on the pharmacokinetics of digoxin and rosuvastatin and to assess the safety of the concomitant administration of bardoxolone methyl with digoxin or rosuvastatin.
Primary Outcome
For Digoxin and Rosuvastatin
Interventions
- DRUG Rosuvastatin
- DRUG Digoxin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-06-30 |
| Est. Completion | 2012-07-31 |
| Phase | Phase 1 |
What the finished NCT01598363 record still lists
NCT01598363 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 2 interventions - of which Rosuvastatin is the first listed.
NCT01598363 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01598363 about?
NCT01598363 is a clinical study titled "An Open-Label Study of the Effect of Bardoxolone Methyl on the Single Dose Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Volunteers". The purpose of this study is to evaluate the potential effect of bardoxolone methyl on the pharmacokinetics of digoxin and rosuvastatin and to assess the safety of the concomitant administration of bardoxolone methyl with digoxin or rosuvastatin.
What is the current status of trial NCT01598363?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2012-06-30. Estimated completion is 2012-07-31.
What interventions are being tested in trial NCT01598363?
The interventions under investigation include: Rosuvastatin (DRUG), Digoxin (DRUG).
Who is sponsoring clinical trial NCT01598363?
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 NCT01598363'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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