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

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

Recruiting
18-75 years
All
Phase 1

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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.

Eligibility

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)

Study details
    Hepatic Impairment
    Healthy Participants

NCT07025551

Merck Sharp & Dohme LLC

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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