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:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT02101112
Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
* Healthy participants as determined by no clinically significant deviation from normal in findings of medical history, physical examination, electrocardiograms, vital signs, and clinical laboratory tests.
* Women of childbearing potential allowed. Must be following highly effective methods of contraception
Exclusion Criteria:
* Any significant acute or chronic medical illness
* History of significant head injury within the last 2 years, including individuals with base of skull fractures
* Any major surgery within 4 weeks of study drug administration or anticipated within 2 weeks after completion of the study
* Any gastrointestinal (GI) surgery or GI disease that could impact absorption of study drug
* History of Gilbert's Syndrome
* Inability to tolerate oral medication
* Inability to be venipunctured and/or tolerate venous access
* Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study drug administration
* Any laboratory test results outside of the range of normal, confirmed by repeat results of:
* Platelet count \<150,000 cells/µL
* Activated partial thromboplastin time \>upper limit of normal (ULN)
* International normalized ratio \>ULN
* Alanine aminotransferase \>ULN
* Aspartate aminotransferase \>ULN
* Total bilirubin \>ULN
* Serum creatinine ≥1.5 mg/dL
* Hemoglobin \<lower limit of normal (LLN)
* Hematocrit \<LLN
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02101112
Study Brief:
Protocol Section:
NCT02101112