Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT02045966
Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead ECG measurements, and clinical laboratory test results
* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/\[height (m)\]2
* Men and women, ages 18 to 45 years, inclusive
* Women must not be of childbearing potential, must not be breastfeeding
Exclusion Criteria:
* Any significant acute or chronic medical illness
* History of important arrhythmias including, but not limited to, ventricular fibrillation, ventricular tachycardia, complete atrioventricular (A-V) block, Wolff-Parkinson-White syndrome
* History of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope
* History of heart disease
* History of prolonged QT interval or torsades de pointes (TdP)
* History of hypokalemia
* Family history of sudden cardiac death at a young age, TdP, or Long QT syndrome
* History of asthma, bronchospasm, or sleep apnea
* History of rhabdomyolysis
* History of a bleeding disorder
* History of Raynaud's disease
* History of peptic ulcer disease or significant gastrointestinal bleed
* History of biliary disorders, including Gilbert's disease or Dubin-Johnson disease
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02045966
Study Brief:
Protocol Section:
NCT02045966