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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT03922633
Eligibility Criteria:
Inclusion Criteria:
1. Non-smoking Japanese males aged 20 to 44 years at the time of written, informed consent
2. Body Mass Index (BMI) at screening is 18.5 or more but less than 25.0 kilogram per square metre (kg/m\^2)
3. Written, informed consent to participate in the study based on the participant's own free will
4. Willing and able to comply with the requirements in the study after being fully informed of the requirements
Exclusion Criteria:
1. Male participants with reproductive potential who and whose partner do not agree to practice medically appropriate contraception (Note: throughout the study)
2. A history or complication of malignant tumor, lymphoma, leukemia, or lymphoproliferative disorder, a clinically significant disease requiring treatments within 8 weeks before the investigational product treatment, or a history of a clinically significant infection within 4 weeks before the investigational product treatment
3. With a psychiatric, digestive, hepatic, renal, respiratory, endocrine, hematologic, neural, or cardiovascular disease within 4 weeks before the investigational product treatment, a congenital metabolic abnormality, or otherwise a disease that may affect the drug assessments
4. With a surgical history (e.g., resection of the liver, kidney, or digestive tract, etc.) at screening that may affect the pharmacokinetics of the investigational product
5. Suspicion of having a clinically abnormal symptom or an organ impairment that requires treatments based on the history/complications at screening or physical findings, vital signs, electrocardiogram findings, or laboratory values at screening or baseline
6. Testing positive for human immunodeficiency virus (HIV) at screening
7. A positive response to a qualitative test for hepatitis B virus surface antigen (HBs antigen), hepatitis B virus core antigen (HBc) antibody, hepatitis C virus (HCV) antibody, or syphilis
8. Use of a prescription drug within 4 weeks before the investigational product treatment
9. Use of an over-the-counter drug within 2 weeks before the investigational product treatment
10. Receiving a vaccine within 4 weeks before the investigational product treatment
11. Ongoing participation in another clinical study or use of an investigational product or device within 16 weeks before the investigational product treatment while participating in another clinical study
12. Receiving blood transfusion within 12 weeks before the investigational product treatment, providing a whole-blood sample of 400 millilitre (mL) or more between 12 to 4 weeks before the investigational product treatment or a whole-blood sample of 200 mL or more within 4 weeks before the investigational product treatment, or giving blood components by pheresis within 2 weeks before the investigational product treatment
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
44 Years
Study:
NCT03922633
Study Brief:
Protocol Section:
NCT03922633