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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT02489435
Eligibility Criteria:
Inclusion Criteria:
1. Provided signed written informed consent;
2. Healthy male subjects, 18-50 years of age;
3. Use of adequate and reliable forms of contraception during the study and 3 months after discontinuation of study medication.
4. ICF signed prior to any study-related procedure.
Exclusion Criteria:
1. HIV, hepatitis B, C antibodies in plasma;
2. Clinical relevant laboratory abnormalities;
3. Active tobacco, alcohol or drug abuse;
4. Anticipated non-compliance with the protocol;
5. Patients who have taken any investigational drug 3 months prior to the start of the study;
6. Plasma donorship, surgery 12 weeks prior to the start of the study;
7. Current significant gastrointestinal, renal, liver, bronchopulmonary, biliary, neurological, cardiovascular, oncologic, allergic, or ophthalmologic diseases, including history of cataracts/lens opacities.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02489435
Study Brief:
Protocol Section:
NCT02489435