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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT02881294
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive) for food and gender effect
* Healthy male aged 60 to 70 years with a BMI between 18 and 32 kg/m2, (inclusive) for age effect
Exclusion Criteria:
* History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the study drug.
* Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody
* History of any important clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02881294
Study Brief:
Protocol Section:
NCT02881294