Multiple-Dose Study of Effect of Bardoxolone Methyl on QT/QTC Interval Volunteers (NCT01689116) | Clinical Trial Compass
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 range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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: