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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT01924832
Eligibility Criteria:
Key Inclusion Criteria:
* Healthy males or non-pregnant, non-lactating healthy females.
* Body mass index (BMI) of 18 through 35 kg/m2.
* Subjects of childbearing potential (including males) must practice effective contraception during the study and be willing and able to continue contraception for 90 days after their last dose of study treatment
Key Exclusion Criteria:
* History of or positive test result at Screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\]).
* Serious infection (e.g., pneumonia, septicemia) within the 3 months prior to first dose.
* Vaccinations within 4 weeks prior to first dose.
* History of drug or alcohol abuse (as defined by the Investigator) within the previous 2 years, or regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint of beer, 25 mL of 40% spirit or a 125 mL glass of wine).
* History of clinically significant gastrointestinal (GI) disease as determined by the Investigator (including Crohn's Disease, Ulcerative Colitis, confirmed diagnosis of active Irritable Bowel Syndrome).
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01924832
Study Brief:
Protocol Section:
NCT01924832