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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT04444050
Eligibility Criteria:
Inclusion Criteria:
* No clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
* A body mass index of 18 - 32 kg/m2, inclusive
* Women and men must agree to follow specific methods of contraception, if applicable
For J-MAD Part 3
* Must be Japanese (both biological parents are ethnically Japanese)
Exclusion Criteria:
* Women who are of childbearing potential
* Women who are pregnant or breastfeeding
* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
* Any surgery within 12 weeks of study drug administration
Other protocol-defined inclusion/exclusion criteria apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04444050
Study Brief:
Protocol Section:
NCT04444050