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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT04313205
Eligibility Criteria:
Inclusion Criteria:
1. The subject has a body mass index (BMI) range of 18.5 and \< 25.0 kg/m2 and weighs at least 50 kg.
2. Agreement for subject and female partner of childbearing potential to use acceptable method of contraception
3. The subject provided written informed consent.
Exclusion Criteria:
1. Any history or evidence of any clinically significant major disease or malignancy, as judged by the Investigator.
2. Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests.
3. Use of prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g. St. John's Wort) in the 2 weeks prior to study drug administration.
4. Consumption of grapefruit, pomelo, citrus fruits, starfruit, pomegranate, papaya, mango, rambutan, kiwi fruit, dragon fruit or passion fruit and products containing these fruits in the 2 weeks prior to study drug administration.
5. Current smoker or history of smoking within 3 months before the Screening Visit.
6. History of drinking more than 21 units of alcohol per week within 3 months prior to the Screening Visit.
7. Any use of drugs-of-abuse within 3 months before the Screening Visit.
8. Any significant blood loss or donation of blood (250 ml within 2 months or 500 ml within 3 months) prior to study drug administration.
9. Positive serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus.
10. Participation in any clinical study or administration of any investigational product within 1 month of study drug administration.
11. The subject has any other condition, which in the opinion of the Investigator precludes the subject's participation in the clinical study.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT04313205
Study Brief:
Protocol Section:
NCT04313205