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 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT06575959
Eligibility Criteria:
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
All participants:
* Has been a non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to starting the study
* Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2
Participants with moderate or mild HI:
* Diagnosis of chronic (\> 6 months) and stable (no sudden or severe episodes of illness due to worsening liver function in the past 2 months) hepatic insufficiency, and features cirrhosis (liver scarring) due to any cause.
* Is generally in good health with the exception of HI.
Healthy Control Participants:
* Medically healthy with no clinically significant medical history, physical examination, or clinical laboratory profiles
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
All participants:
* History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery.
* History of cancer
* Consumes greater than 3 servings of alcoholic beverages per day.
* Is on statin background therapy.
Participants with moderate or mild HI:
* Severe complications of liver disease within 3 months of entering the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06575959
Study Brief:
Protocol Section:
NCT06575959