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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT03369002
Eligibility Criteria:
Inclusion Criteria:
* Must have given written informed consent (signed and dated) and any authorizations required by local law.
* Willing to be confined to CRU for the entire duration required by the protocol.
* Male or female, between 18 and 80 years of age.
* Healthy subject with normal liver function must be non-smoker and no use of other tobacco or nicotine-containing products. Subject with HI must be non-smoker, or smoke ≤10 cigarettes per day during the study.
* Healthy subject must not be taking any prescribed or non-prescribed medications unless permitted. Subject with HI will be allowed to take their chronic medications unless excluded by the protocol.
Exclusion Criteria:
* Pregnant or lactating women.
* Treatment with another investigational drug or device within 30 days prior to study drug administration.
* Has donated or lost a significant volume of blood within 56 days or plasma within 7 days prior to Check-in day.
* Inability to swallow medication.
* Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1.
* Positive test at Screening for HBsAg, hepatitis C virus (HCV), or HIV.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03369002
Study Brief:
Protocol Section:
NCT03369002