Status:
RECRUITING
A Study of MK-1084 in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Healthy
Hepatic Impairment
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT07219550
Start Date
November 5 2025
End Date
June 30 2026
Last Update
December 24 2025
Active Locations (3)
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1
Arizona Clinical Trials ( Site 0003)
Chandler, Arizona, United States, 85225
2
Orlando Clinical Research Center ( Site 0001)
Orlando, Florida, United States, 32809
3
The Texas Liver Institute ( Site 0002)
San Antonio, Texas, United States, 78215