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

Merck Sharp & Dohme (MSD)

Status and phase

Enrolling

Phase 1

Conditions

Hepatic Impairment

Healthy

Treatments

Drug: MK-1084

Study type

Interventional

Funder types

Industry

Identifiers

NCT07219550

1084-017

MK-1084-017 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

58 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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