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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT03055403
Eligibility Criteria:
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
* Japanese Healthy Male subjects
* Age 20 to less than 40 years of age
* Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2
* Written informed consent must be obtained on a voluntary basis before any assessment is performed.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
* Presence or past medical history of hepatic impairments, renal impairments, cardiovascular disease, gastrointestinal disease and others which are inappropriate for participating in this clinical trial
* Past medical history of cancer, cerebral infarction or cardiac infarction
* Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials
* QTcF \> 450ms at the screening examination
* NT-proBNP \> 125 pg/mL at the screening examination
* Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
39 Years
Study:
NCT03055403
Study Brief:
Protocol Section:
NCT03055403