A Study of MK-1084 in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
NCT ID: NCT07219550
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
58 participants
INTERVENTIONAL
2025-11-05
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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MK-1084
All participants will receive a single oral dose of MK-1084 on Day 1.
MK-1084
Oral Tablet
Interventions
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MK-1084
Oral Tablet
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Arizona Clinical Trials ( Site 0003)
Chandler, Arizona, United States
Orlando Clinical Research Center ( Site 0001)
Orlando, Florida, United States
The Texas Liver Institute ( Site 0002)
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-1084-017
Identifier Type: OTHER
Identifier Source: secondary_id
1084-017
Identifier Type: -
Identifier Source: org_study_id