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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT01967966
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) 18 to 32 kg/m2, inclusive;
* Healthy, as judged by physician from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations;
* Agree to use effective contraceptive methods as defined by protocol;
* Negative hepatitis panel and HIV screen;
* Sufficient bowel movements (minimum of 1 per day).
Exclusion Criteria:
* History or clinical manifestation of: any major medical disorders; any food/drug/substance allergies;
* History of stomach or intestinal surgery or resection except for appendectomy and/or hernia repair;
* History of alcoholism or drug addiction within 1 year prior to drug administration;
* Tobacco or nicotine use within 6 months prior to study start;
* Chronic use of gastric acid inhibitors within 6 months of study start or use of gastric acid inhibitors and/or antacids within 1 month prior to drug administration;
* Evidence of malabsorption syndrome or other condition interfering with gastrointestinal absorption;
* Inability or unwillingness to swallow capsules;
* Participation in a drug study in which a drug was administered within 30 days prior to study start;
* Participation in more than one radiolabeled drug study within 12 months preceding drug administration. The previous radiolabeled study drug must have been received more than 6 months prior to this study, and the total exposure from this study and the previous study is less than 5000 mrem whole body annual exposure;
* Exposure to significant radiation within 12 months prior to study start.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01967966
Study Brief:
Protocol Section:
NCT01967966