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

NCT07219550

CompletedPhase 1

Sponsor: Merck Sharp & Dohme LLC

Conditions: Healthy, Hepatic Impairment

Interventions: Calderasib

Countries: United States

The purpose of this study is to learn what happens to calderasib levels in a person's body over time. Researchers will measure what happens to calderasib 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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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

Healthy volunteers:

* Has positive results for HBsAg or HCV

Locations (3)

Chandler, Arizona, United States
Orlando, Florida, United States
San Antonio, Texas, United States