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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT01970020
Eligibility Criteria:
Inclusion Criteria:
* Healthy, male participants with a body mass index 18 to 30 kg/m2 (inclusive) and a body weight not less than 50 kg
* Must use adequate contraception and not donate sperm during study and for 90 days after receiving the study medication
* Non-smoker and blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
* Have a 12-lead ECG consistent with normal cardiac conduction and function at screening
Exclusion Criteria:
* Exposure to radiation for professional or medical reasons in the past 12 months
* Recent changes in bowel habits (frequency, consistency, and amount) and irregular defecation pattern (less than one defecation per day)
* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease and coagulation disorders
* History of malignancy within 5 years before screening
* Has received a Bacille Calmette-Guérin vaccination within 12 months or any other live bacterial or live viral vaccination within 12 weeks prior to the first administration of study agent
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01970020
Study Brief:
Protocol Section:
NCT01970020