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:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT03499106
Eligibility Criteria:
Inclusion Criteria:
* Subject is an ambulatory adult between 18 and 75 years old at the screening visit
* Subject is in good health and has no clinically significant findings on physical examination
* Body mass index is \> 18 and \< 30.0 kg/m2 at the screening visit
* Women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 2 months after the final dose of study drug
* Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 2 months after the final dose of study drug
* Other inclusion criteria per protocol
Exclusion Criteria:
* Any active or unstable clinically significant medical condition
* Use of any prescribed or non-prescribed medication
* Other exclusion criteria per protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03499106
Study Brief:
Protocol Section:
NCT03499106