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 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT02581592
Eligibility Criteria:
Inclusion Criteria:
* For hepatic impairment group: Subject has moderate hepatic impairment (Child Pugh B)
* For normal hepatic function group: Subject is in good health
Exclusion Criteria:
* Women who are pregnant, lactating, breastfeeding, or planning to become pregnant during the study.
* Subject has received an investigational drug (or medical device) within 30 days
* Subject who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition that would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or is unable to comply with the study protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02581592
Study Brief:
Protocol Section:
NCT02581592