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

This study is looking at a drug called Calderasib (MK-1084) to understand how it moves through the body in people with liver problems (hepatic impairment) and in healthy individuals. Researchers want to see how much Calderasib is in the body over time and how safe and tolerable it is for people with liver impairment. You might be able to join if you are between 18 and 80 years old and have a BMI between 18.0 and 42.0. Participants with liver impairment must have a chronic, stable diagnosis of liver insufficiency with cirrhosis. Healthy volunteers must be medically healthy. The study aims to enroll 58 participants.

Study design
This is an interventional study involving 58 participants, including both healthy volunteers and individuals with hepatic impairment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure drug levels for up to approximately 7 days after you take the dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07219550

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

Completed
PHASE1Ages 18–80InterventionalBasic science
Merck Sharp & Dohme LLC
~32 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Calderasib

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib
Measured over At designated timepoints up to approximately 7 days post-dose
+7 more outcomes measured

Conditions

Healthy
Hepatic Impairment

Explore related trials

HealthyLiver Failure

Where it's being run

3 sites across 3 states
Arizona1
Florida1
Texas1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Has a body mass index (BMI) between 18.0 and 42.0 kg/m\^2
Has a diagnosis of chronic, stable hepatic insufficiency at screening with features of cirrhosis
Is medically healthy with no clinically significant medical history

Exclusion

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
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
Has positive results for HBsAg or HCV

What this trial measures

  • Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of CalderasibAt designated timepoints up to approximately 7 days post-dose

    Blood samples will be collected to determine the AUC0-last of calderasib in plasma.

  • Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of CalderasibAt designated timepoints up to approximately 7 days post-dose

    Blood samples will be collected to determine the AUC0-inf of calderasib in plasma.

  • Area Under the Concentration Versus Time Curve from 0 to 24 hours post-dose (AUC0-24) of CalderasibUp to approximately 24 hours post-dose

    Blood samples will be collected to determine the AUC0-24 of calderasib in plasma.

  • Maximum Observed Drug Concentration (Cmax) of CalderasibAt designated timepoints up to approximately 7 days post-dose

    Blood samples will be collected to determine the Cmax of calderasib in plasma.

  • Time to Maximum Observed Drug Concentration (Tmax) of CalderasibAt designated timepoints up to approximately 7 days post-dose

    Blood samples will be collected to determine the Tmax of calderasib in plasma.

  • Apparent Terminal Half-life (t1/2) of CalderasibAt designated timepoints up to approximately 7 days post-dose

    Blood samples will be collected to determine the t1/2 of calderasib in plasma.

  • Apparent Clearance (CL/F) of CalderasibAt designated timepoints up to approximately 7 days post-dose

    Blood samples will be collected to determine the CL/F of calderasib in plasma.

  • Apparent Volume of Distribution During Terminal Phase (Vz/F) of CalderasibAt designated timepoints up to approximately 7 days post-dose

    Blood samples will be collected to determine the Vz/F of calderasib in plasma.