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

Merck Sharp & Dohme LLC18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Hepatic Impairment Healthy Participants

Interventions

MK-8527DRUG

Oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Arizona Clinical Trials ( Site 0001)

Chandler, Arizona, United States

Outcomes

Primary Outcomes

Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of MK-8527

Plasma samples will be collected at pre-specified timepoints to determine the AUC0-last of MK-8527.