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A Study of MK-1084 in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)

A Study of MK-1084 in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)

Recruiting
18-80 years
All
Phase 1

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Overview

The purpose of this study is to learn what happens to MK-1084 levels in a person's body over time. Researchers will measure what happens to MK-1084 levels in the body when it is given to participants with hepatic (liver) impairment and healthy participants. Researchers also want to learn about the safety of MK-1084 when it is given to people with hepatic impairment and if people with hepatic impairment can tolerate it.

Eligibility

The main inclusion criteria include but are not limited to:

All participants:

  • Has a body mass index (BMI) between 18.0 and 42.0 kg/m\^2

Participants with hepatic impairment (HI):

  • Has a diagnosis of chronic, stable hepatic insufficiency at screening with features of cirrhosis

Healthy volunteers:

  • Is medically healthy with no clinically significant medical history

The main exclusion criteria include but are not limited to:

All participants:

  • Has a history of gastrointestinal disease which may affect food and drug absorption
  • Has a history of cancer (malignancy)
  • Has a positive result 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 HI:

  • Has had severe complications of liver disease within the preceding 3 months of screening
  • Has a history of recent (within 3 months prior to screening) variceal bleeds
  • Has evidence of hepatorenal syndrome
  • Is not in sufficient health, with regard to stability of HI, to undergo participation in the study with anticipated survival of \< 3 months
  • Has a history of liver or other solid organ transplantation
  • Has an active infection requiring systemic therapy
  • Requires paracentesis more often than 2 times per month
  • Has transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting
  • Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to dosing
  • Is using HIV protease inhibitors
  • Is positive for Hepatitis B surface antigen (HBsAg)
  • Is positive for HCV

Healthy volunteers:

  • Has positive results for HBsAg or HCV

Study details
    Healthy
    Hepatic Impairment

NCT07219550

Merck Sharp & Dohme LLC

1 February 2026

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FAQs

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

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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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