Trials / Completed
CompletedNCT01689116
Multiple-Dose Study of Effect of Bardoxolone Methyl on QT/QTC Interval Volunteers
A Blinded Randomized Parallel Trial to Define the ECG Effects of Bardoxolone Methyl Using a Clinical and a Supratherapeutic Dose Compared to Placebo and Moxifloxacin (a Positive Control) in Healthy Men and Women: A Thorough ECG Trial.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 179 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This is a single-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, active-comparator, parallel study in healthy volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bardoxolone Methyl 20mg | Oral |
| DRUG | Bardoxolone Methyl 80mg | Oral |
| DRUG | Bardoxolone Methyl Placebo | Oral |
| DRUG | Moxifloxacin 400mg | Oral |
| DRUG | Moxifloxacin Placebo | Oral |
Timeline
- Start date
- 2012-08-31
- Primary completion
- 2012-11-30
- Completion
- 2012-11-30
- First posted
- 2012-09-21
- Last updated
- 2025-05-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01689116. Inclusion in this directory is not an endorsement.