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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT07219550
Eligibility Criteria:
The main inclusion criteria include but are not limited to:
All participants:
* Has a body mass index (BMI) between 18.0 and 42.0 kg/m\^2
Participants with hepatic impairment (HI):
* Has a diagnosis of chronic, stable hepatic insufficiency at screening with features of cirrhosis
Healthy volunteers:
* Is medically healthy with no clinically significant medical history
The main exclusion criteria include but are not limited to:
All participants:
* Has a history of gastrointestinal disease which may affect food and drug absorption
* Has a history of cancer (malignancy)
* Has a positive result 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 HI:
* Has had severe complications of liver disease within the preceding 3 months of screening
* Has a history of recent (within 3 months prior to screening) variceal bleeds
* Has evidence of hepatorenal syndrome
* Is not in sufficient health, with regard to stability of HI, to undergo participation in the study with anticipated survival of \< 3 months
* Has a history of liver or other solid organ transplantation
* Has an active infection requiring systemic therapy
* Requires paracentesis more often than 2 times per month
* Has transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting
* Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to dosing
* Is using HIV protease inhibitors
* Is positive for Hepatitis B surface antigen (HBsAg)
* Is positive for HCV
Healthy volunteers:
* Has positive results for HBsAg or HCV
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07219550
Study Brief:
Protocol Section:
NCT07219550