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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT05437120
Eligibility Criteria:
Key Inclusion Criteria:
* Cohort 1: Participants with Moderate Hepatic Impairment
* Participants will satisfy the criteria for moderate hepatic impairment defined as a Child-Pugh total score of 7 to 9 points at the screening visit
* Participants will have chronic (≥6 months) documented liver disease
* Cohort 2: Matched Healthy Participants
* Participants will be matched during screening to participants with hepatic impairment for cigarette smoking habit, age, sex, and weight
Key Exclusion Criteria:
* Cohort 1: Participants with Moderate Hepatic Impairment
* History of febrile illness or other acute illness
* History of solid organ or bone marrow transplantation
* History or presence of severe hepatic encephalopathy (Grade \>2)
* Any condition possibly affecting drug absorption
* Severe portal hypertension
* Significant renal dysfunction (creatinine clearance \<50 milliliter per minute \[mL/min\] ) estimated according to the method of Cockcroft and Gault at the screening Visit or Day-1
* Cohort 2: Matched Healthy Participants
* History of febrile illness or other acute illness
* Any condition possibly affecting drug absorption
Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05437120
Study Brief:
Protocol Section:
NCT05437120