CompletedPhase 1

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

United States179 participantsStarted 2012-08-31

Plain-language summary

This is a single-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, active-comparator, parallel study in healthy volunteers.

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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:

What they're measuring

Change in QT/QTc interval

Timeframe: Baseline, Day 6 and Day 13

Trial details

NCT IDNCT01689116

SponsorBiogen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-11-30

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