Multiple-Dose Study of Effect of Bardoxolone Methyl on QT/QTC Interval Volunteers
NCT01689116 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 179
Last updated 2025-05-29
Summary
This is a single-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, active-comparator, parallel study in healthy volunteers.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
Bardoxolone Methyl 20mg
Oral
- DRUG
-
Bardoxolone Methyl 80mg
Oral
- DRUG
-
Bardoxolone Methyl Placebo
Oral
- DRUG
-
Moxifloxacin 400mg
Oral
- DRUG
-
Moxifloxacin Placebo
Oral
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-08-31
- Primary Completion
- 2012-11-30
- Completion
- 2012-11-30
Countries
- United States
Study Locations
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