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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT06444204
Eligibility Criteria:
Inclusion Criteria:
* Hepatic Impaired Subjects:
* Non-smoking or light smoker (not exceeding 5 cigarettes per day), adult male or non-pregnant, non-lactating female, 18-75 years of age, inclusive, at screening.
* Weight ≥ 50 kg, at screening.
* Healthy Subjects:
* Non-smoking or light smoker (not exceeding 5 cigarettes per day), healthy, adult males and non-pregnant, non-lactating females, 18-75 years of age, inclusive, at screening.
Subject must be matched for age (within ± 10 years), and sex of the matched subject with hepatic impairment.
--Weight ≥ 50 kg at screening.
Additional inclusion criteria might apply.
Exclusion Criteria:
* Hepatic Impaired Subjects:
* Pregnant or lactating female.
* Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 millimeters of mercury \[mmHg\] and/or diastolic blood pressure ≥ 105 mmHg), or resting pulse rate \< 45 or \> 100 beats per minute (bpm). Measurements may be repeated once in order to determine eligibility.
* Healthy Subjects
* Pregnant or lactating female.
* Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg), or resting pulse rate \< 45 or \> 100 bpm. Measurements may be repeated once in order to determine eligibility.
Additional exclusion criteria might apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06444204
Study Brief:
Protocol Section:
NCT06444204