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 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT03014895
Eligibility Criteria:
Inclusion Criteria:
Main Inclusion Criteria:
* Non-smoking, Japanese, male participants, ≥20 and \<45 years old at the time of obtaining informed consent
* Have a Body Mass Index (BMI) ≥18.5 and \<25.0 kilograms per meters squared (kg/m\^2) at Screening
* Able to provide written informed consent of their free will
* Males who were given a full explanation of all the requirements of the protocol, and are willing and able to comply with them
Exclusion Criteria:
Main Exclusion Criteria:
* Male and his partner who do not agree to use a highly effective method of contraception throughout the entire study period, if he has reproductive capacity
* Male who had or has any malignant tumor, lymphoma, leukaemia, or lymphoproliferative disorders. Clinically significant illness that required medical treatment within 8 weeks or a clinically significant infection within 4 weeks prior to dosing.
* Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing
* Any history of surgical treatment that may affect pharmacokinetic (PK) profiles of study drug at Screening
* Any suspected clinically abnormal symptom or organ impairment that require medical treatment at Screening or Baseline
* Receipt of vaccination within 4 weeks prior to dosing
* History of drug or alcohol dependency or abuse prior to Screening
* Intake of caffeinated beverages or food within 72 hours prior to dosing
* Use of prescription drugs within 4 weeks prior to dosing
* Intake of over-the-counter (OTC) medications within 2 weeks prior to dosing
* Male who is currently being enrolled in another clinical study or used any investigational drug or device in another clinical study within 16 weeks prior to dosing
* Male who underwent a blood transfusion within 12 weeks prior to dosing, who donate 400 milliliters (mL) or more of whole blood within 12 weeks prior to dosing, who donate 200 mL or more of whole blood within 4 weeks prior to dosing, or who made a component donation within 2 weeks prior to dosing
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
44 Years
Study:
NCT03014895
Study Brief:
Protocol Section:
NCT03014895