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

NCT07025551 | Completed Phase 1 FDA Drug

• 2 other identifiers: 8527-015MK-8527-015
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatic Impairment; Healthy Participants

Outcome Measures

Primary Outcomes (7)

• 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.

  Predose and at designated timepoints up to 168 hours post dose

• Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-8527

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

  Predose and at designated timepoints up to 168 hours post dose

• Maximum Observed Concentration (Cmax) of MK-8527

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

  Predose and at designated timepoints up to 168 hours post dose

• Time to Maximum Concentration (Tmax) of MK-8527

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

  Predose and at designated timepoints up to 168 hours post dose

• Apparent Terminal Half-life (t1/2) of MK-8527

  Plasma samples will be collected at pre-specified timepoints to determine the t1/2 of MK-8527.

  Predose and at designated timepoints up to 168 hours post dose

• Apparent Clearance (CL/F) of MK-8527

  Plasma samples will be collected at pre-specified timepoints to determine the CL/F of MK-8527.

  Predose and at designated timepoints up to 168 hours post dose

• Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527

  Plasma samples will be collected at pre-specified timepoints to determine the Vz/F of MK-8527.

  Predose and at designated timepoints up to 168 hours post dose

Secondary Outcomes (8)

• Number of Participants Who Experience One or More Adverse Events (AEs)

  Up to approximately 29 days

• Number of Participants Who Discontinue Study Due to an AE

  Up to approximately 29 days

• AUC0-inf of MK-8527-triphosphate (TP) in peripheral blood mononuclear cell (PBMCs)

  Predose and at designated timepoints up to 672 hours post dose

• Area under the concentration versus time curve from 0 to 672 hours after dosing (AUC0-672hrs) of MK-8527-TP in PBMCs

  At designated timepoints pre dose and up to approximately 672 hours post dose

• Cmax of MK-8527-TP in PBMCs

  Predose and at designated timepoints up to 672 hours post dose

Study Arms (3)

Mild Hepatic Impairment (Group 1)

EXPERIMENTAL

All participants will receive a single dose of MK-8527 on Day 1.

Drug: MK-8527

Moderate Hepatic Impairment (Group 2)

EXPERIMENTAL

All participants will receive a single dose of MK-8527 on Day 1.

Drug: MK-8527

Healthy (Group 3)

EXPERIMENTAL

All participants will receive a single dose of MK-8527 on Day 1.

Drug: MK-8527

Interventions

MK-8527 DRUG

Oral administration

Healthy (Group 3); Mild Hepatic Impairment (Group 1); Moderate Hepatic Impairment (Group 2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Arizona Clinical Trials ( Site 0001)

Chandler, Arizona, 85225, United States

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: September 19, 2025
• Primary Completion: February 13, 2026
• Study Completion: February 13, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)