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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT05919069
Eligibility Criteria:
Inclusion Criteria:
For Hepatic:
* Participant with a diagnosis of chronic and stable hepatic impairment
For Healthy:
* Participant with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or 12-lead ECGs,
All participants:
\- Body weight ≥ 50 kg; BMI within the range of 18.0 to 40.0 kg/m2 (inclusive) as measured at screening
Exclusion Criteria:
* Participant with impaired hepatic function has eGFR \< 60 mL/minute/1.73 m2 and participant with normal hepatic function has eGFR \< 90 mL/minute/1.73 m2
* Positive test for HIV at screening
* History or presence of clinically significant thyroid disease
* History or presence of clinically significant or unstable medical or psychiatric condition
* History of any major surgical procedure within 30 days prior to study intervention
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05919069
Study Brief:
Protocol Section:
NCT05919069