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NCT01689116 · ClinicalTrials.gov registry record · Phase 1
Multiple-Dose Study of Effect of Bardoxolone Methyl on QT/QTC Interval Volunteers
A Phase 1 study of Healthy Volunteers, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 179
- Enrollment target
- 1
- Study location
NCT01689116: Completed Phase 1 study of Healthy Volunteers, sponsored by Biogen.
NCT01689116 is a Phase 1 study of Healthy Volunteers that has completed, run by Biogen. The registered enrollment target is 179 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01689116, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 179 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, active-comparator, parallel study in healthy volunteers.
Conditions Studied
Interventions
- DRUG Moxifloxacin Placebo
- DRUG Moxifloxacin 400mg
- DRUG Bardoxolone Methyl 20mg
- DRUG Bardoxolone Methyl 80mg
- DRUG Bardoxolone Methyl Placebo
Study Locations (1)
Wisconsin
- Spaulding Clinical Research, LLC - West Bend
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2012-08-31 |
| Est. Completion | 2012-11-30 |
| Phase | Phase 1 |
What the finished NCT01689116 record still lists
NCT01689116 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 5 interventions - of which Moxifloxacin Placebo is the first listed.
NCT01689116 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01689116 about?
NCT01689116 is a clinical study titled "Multiple-Dose Study of Effect of Bardoxolone Methyl on QT/QTC Interval Volunteers". This is a single-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, active-comparator, parallel study in healthy volunteers.
What is the current status of trial NCT01689116?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 179 participants. The study started on 2012-08-31. Estimated completion is 2012-11-30.
What conditions does trial NCT01689116 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT01689116?
The interventions under investigation include: Moxifloxacin Placebo (DRUG), Moxifloxacin 400mg (DRUG), Bardoxolone Methyl 20mg (DRUG), Bardoxolone Methyl 80mg (DRUG), Bardoxolone Methyl Placebo (DRUG).
Who is sponsoring clinical trial NCT01689116?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01689116 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01689116's enrollment target sits among peer trials
179 53rd of 283 higher than 231 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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