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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT07025551
Eligibility Criteria:
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
All participants:
* Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing
* Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m\^2
Participants with Mild HI (Group 1) and Moderate HI (Group 2):
* Has mild or moderate hepatic impairment
* Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology
* Is generally in good health with the exception of HI
Healthy Control Participants (Group 3):
\- Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
All participants:
* Has a history of cancer (malignancy)
* Has positive results for human immunodeficiency virus (HIV)
* Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing
Participants with Mild HI (Group 1) and Moderate HI (Group 2):
* With the exception of HI, has a history or presence of clinically significant medical or psychiatric condition or disease
* Is positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb)
* Is positive for Hepatitis C Virus (HCV)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07025551
Study Brief:
Protocol Section:
NCT07025551