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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT02704702
Eligibility Criteria:
Inclusion Criteria:
1. Caucasian male 19-55 years of age.
2. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
3. Medically healthy with no clinically significant medical history.
4. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
Exclusion Criteria:
1. History or presence of clinically significant medical or psychiatric condition or disease.
2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
3. Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.
4. Plasma donation within 7 days prior to the first dose of study drug.
5. Participation in another clinical trial within 28 days prior to the first dose of study drug(s).
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT02704702
Study Brief:
Protocol Section:
NCT02704702