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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT04470908
Eligibility Criteria:
Key Inclusion Criteria:
1. Males of any race, between 18 and 65 years of age, inclusive.
2. Male participants in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening
3. Must have a body mass index (BMI) between 18 and 32 kg/m\^2
Key Exclusion Criteria:
1. Participants with a clinically relevant history or presence of any clinically significant disease
2. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed)
3. History of drug or alcohol abuse within 1 year prior to check-in
4. Use or intended use of any nonprescription medications/products including vitamins, minerals, herbal/plant-derived preparations within 7 days prior to check-in
5. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result and/or a positive human immunodeficiency virus (HIV) at screening
6. Use of tobacco- or nicotine-containing products within 3 months prior to check-in
7. Use or intended use of any prescription medications/products within 14 days prior to check-in
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04470908
Study Brief:
Protocol Section:
NCT04470908