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:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT02095860
Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
* Healthy male and female subjects ages 18 to 49 years, inclusive.
* Women of childbearing potential must be using an acceptable method of contraception for at least 4 weeks prior to study drug administration.
Exclusion Criteria:
* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy
* History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease
* Use of tobacco-containing or nicotine-containing products
* Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration, confirmed by repeat:
* PR ≥210 msec
* QRS ≥120 msec
* QT ≥500 msec
* QTcF ≥450 msec
* Any of the following laboratory results outside of the ranges specified below prior to study drug administration, confirmed by repeat:
* Alanine aminotransferase (ALT) \>Upper limit of normal (ULN)
* Aspartate aminotransferase (AST) \>ULN
* Total bilirubin (TBILI) \>ULN
* Creatinine \>ULN
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT02095860
Study Brief:
Protocol Section:
NCT02095860