ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-8527 in Participants With Mild and Moderate Hepatic Impairment

Quick Facts

Study Start:2025-09-19

Study Completion:2026-02-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07025551

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 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	* 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 * 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)

Inclusion Criteria

Exclusion Criteria

* 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 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

* 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
* 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)

Contacts and Locations

Principal Investigator

Medical Director

STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Locations (Sites)

Arizona Clinical Trials ( Site 0001)

Chandler, Arizona, 85225

United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-19

Study Completion Date2026-02-04

Study Record Updates

Study Start Date2025-09-19

Study Completion Date2026-02-04

Terms related to this study

Additional Relevant MeSH Terms

Hepatic Impairment
Healthy Participants