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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT04023903
Eligibility Criteria:
Inclusion Criteria:
1\) Written voluntary informed consent to participate in the study; 2) \[Food Effect Part\] Japanese men 20 to \<40 years of age at informed consent; \[Caucasian Subject Part\] Caucasian men 20 to \<40 years of age at informed consent; 3) BMI 18.5 kg/m2 to \<25.0 kg/m2 at screening
Exclusion Criteria:
1. Presence of any disease requiring treatment;
2. History of heart failure (e.g., history of diagnosis of congestive heart failure categorized as Class III or IV of the New York Heart Association (NYHA) Functional Classification or history of hospitalization due to heart failure);
3. Alcoholism or drug addiction, or any positive result on drug abuse testing;
4. History of or current drug allergy;
5. Any positive result on infectious disease testing. Individuals who are positive for active antibodies produced by hepatitis B vaccination and are not infected with hepatitis B virus at screening can be enrolled in the study;
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
39 Years
Study:
NCT04023903
Study Brief:
Protocol Section:
NCT04023903