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

Completed · Phase 1

Conditions studied: Hepatic Impairment, Healthy Participants

In brief

The purpose of this study is to learn what happens to MK-8527 in a person's body over time (a pharmacokinetic \[PK\] study). Researchers will compare what happens to MK-8527 in the body when it is given to healthy participants and participants with mild and moderate hepatic (liver) impairment.

Key facts

Study ID

NCT07025551

Run by

Merck Sharp & Dohme LLC

People needed

18

Starts

2025-09-19

Expected to finish

2026-02-13

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Arizona Clinical Trials ( Site 0001) — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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