A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015)

Launched by MERCK SHARP & DOHME LLC · Jun 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a medicine called MK-8527 behaves in the body, especially in people who have mild or moderate liver problems. The goal is to see if the liver condition changes the way the medicine is absorbed, processed, or removed from the body. To do this, researchers will compare results from people with liver impairment to those from healthy volunteers.

People who may be eligible for this study include adults with stable, mild or moderate liver problems, as well as healthy adults without any significant medical issues. Participants need to be non-smokers or moderate smokers and have a body weight within a certain range. If you join the study, you can expect to have your health carefully checked before and during the trial to make sure it’s safe for you. It’s important to note that people with serious illnesses like cancer, HIV, or active hepatitis infections will not be able to participate. This study is still not open for enrollment, but it aims to help doctors better understand how MK-8527 works in people with different liver health.

Gender

ALL

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
• • Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology
• Participants with Mild HI (Group 1) and Moderate HI (Group 2):
• • Has mild or moderate hepatic impairment
• • 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 Virus (HBV)
• • Is positive for Hepatitis C Virus (HCV)