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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT03133468
Eligibility Criteria:
Inclusion Criteria:
Main Inclusion Criteria for all participants:
* Participants will be male
* Participants will be in good health
Main Inclusion Criteria for Japanese participants:
* Be ≥20 to ≤45 years of age
* Have body mass index (BMI) ≥18.5 to ≤25.0 kilograms per meters squared (kg/m\^2)
* Be Japanese
Main Inclusion Criteria for Caucasian participants:
* Be ≥18 to ≤45 years of age
* Have a BMI ≥18.5 to ≤30.0 kg/m\^2
* Be Caucasian
Exclusion Criteria:
Main Exclusion Criteria for all participants:
Participants will be excluded from the study if they satisfy any of the following criteria at the Screening visit, unless otherwise stated.
* Participants who have donated or lost ≥200 milliliters (mL) blood within 1 month or ≥400 mL within 3 months prior to Check-in
* Participants who have an abnormality in heart rate, blood pressure, temperature, or respiration rate at Screening
* Participants who have:
* a positive urine drugs of abuse screen;
* a positive alcohol breath test
* Participants who have an abnormality in the 12-lead electrocardiogram (ECG) at Screening
* Participants who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to first dose administration
* Participants who have a significant history of drug allergy, as determined by the Investigator
* Participants who have any clinically significant abnormal physical examination finding
* Participants who:
* are carriers of the hepatitis B surface antigen (HBsAg);
* are carriers of the hepatitis C antibody;
* have a positive result for the test for human immunodeficiency virus (HIV) antibodies
* Participants who, in the opinion of the Investigator, should not participate in this study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03133468
Study Brief:
Protocol Section:
NCT03133468