Multiple-Dose Study of Effect of Bardoxolone Methyl on QT/QTC Interval Volunteers

NCT01689116 | Completed Phase 1

• 1 other identifier: 402-C-1006
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in QT/QTc interval

  Baseline, Day 6 and Day 13

Secondary Outcomes (7)

• Maximum observed concentration

  Day 1 and Day 6

• Time to maximum observed concentration

  Day 1 and Day 6

• Area under the plasma concentration-time curve from time 0 to last observed concentration

  Day 1 and Day 6

• Area under curve for the dosing interval

  Day 1 and Day 6

• Accumulation index for maximum observed concentration

  Day 1 and day 6

Study Arms (4)

Bardoxolone Methyl 20mg

EXPERIMENTAL

Drug: Bardoxolone Methyl 20mg; Drug: Bardoxolone Methyl Placebo; Drug: Moxifloxacin Placebo

Bardoxolone Methyl 80mg

EXPERIMENTAL

Drug: Bardoxolone Methyl 80mg; Drug: Moxifloxacin Placebo

Bardoxolone Methyl Placebo

PLACEBO COMPARATOR

Drug: Bardoxolone Methyl Placebo; Drug: Moxifloxacin Placebo

Moxifloxacin

ACTIVE COMPARATOR

Drug: Bardoxolone Methyl Placebo; Drug: Moxifloxacin 400mg

Interventions

Bardoxolone Methyl 20mg DRUG

Oral

Bardoxolone Methyl 20mg

Bardoxolone Methyl 80mg DRUG

Oral

Bardoxolone Methyl 80mg

Bardoxolone Methyl Placebo DRUG

Oral

Bardoxolone Methyl 20mg; Bardoxolone Methyl Placebo; Moxifloxacin

Moxifloxacin 400mg DRUG

Oral

Moxifloxacin

Moxifloxacin Placebo DRUG

Oral

Bardoxolone Methyl 20mg; Bardoxolone Methyl 80mg; Bardoxolone Methyl Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All subjects must meet all of the following criteria to be included in the study:
• Healthy male and female subjects between 18 to 50 years of age, inclusive. Healthy as determined by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measurements performed at screening;
• BMI greater than or equal to 18 kg/m2 but not to exceed 32 kg/m2;
• Female subjects of childbearing potential must not be planning a pregnancy, pregnant, or lactating, and must have a negative serum pregnancy test result before enrollment into the study, and must be willing to use contraception as specified in section 12.8.3 or abstain from sexual activity for the duration of the study and for at least 3 weeks after discontinuation of study drug;
• Male subjects and their partners of childbearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for 30 days after completion;
• Agree to abstain from alcohol consumption up to 3 days before dosing and throughout duration of the study (including the Study Day 13 visit);
• Agree to abstain from strenuous exercise from 3 days before dosing and throughout duration of the study (including the Study Day 13 visit);
• Able to effectively communicate with the investigator and other testing center personnel;
• Able to participate, and willing to give written informed consent and to comply with the study restrictions.

You may not qualify if:

• All subjects with any of the following conditions or characteristics must be excluded from the study:
• Currently participating in another study of an investigational drug (or a medical device) or have participated in another clinical study of an investigational drug (or a medical device) within 30 days of Study Day -1, 5 half-lives or twice the duration of biological effect of the previous investigational drug (whichever is longer);
• Known hypersensitivity to any component in the formulation of the study drug, bardoxolone methyl;
• Any medical or dental procedure, no matter how minor, that is planned or anticipated to occur during the conduct of the study;
• History of drug or alcohol abuse or dependence within the last year;
• History of smoking or tobacco use within the 6 months prior to Study Day -1;
• Donation or receipt of blood or blood components within the 4 weeks prior to Study Day -1. The investigator should instruct subjects who participate in this study not to donate blood or blood components for 4 weeks after the completion of the study;
• History of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or Torsades de Pointes, structural heart disease, or family history of long QT syndrome (suggested by sudden death due to cardiac causes at a young age of a close relative);
• Evidence of any of the following cardiac conduction abnormalities based on the safety ECG at Screening:
• Fridericia's correction for QT (QTcF) interval \> 450 ms for males, \> 470 ms for females;
• PR interval \< 110 ms or \> 240 ms;
• Intraventricular conduction delay with QRS duration \>120 ms;
• Resting heart rate \< 40 bpm or \> 90 bpm;
• Pathological Q-waves (defined as Q-wave \> 40 ms or depth \> 0.4-0.5 mV);
• Second- or third-degree atrioventricular block (AVB);

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Spaulding Clinical Research, LLC

West Bend, Wisconsin, 53012, United States

Location

MeSH Terms

Interventions

bardoxolone methyl; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: September 21, 2012
• Study Start: August 31, 2012
• Primary Completion: November 30, 2012
• Study Completion: November 30, 2012
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)