Calderasib (MK-1084) in people with liver impairment and healthy volunteers

A Clinical Study to Evaluate the Effect of Hepatic Impairment on the Single-Dose Pharmacokinetics of MK-1084

This test gives calderasib to adults with stable liver impairment and to healthy volunteers to see how the drug is processed in the body and whether people with liver problems can tolerate it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Merck Sharp & Dohme LLC (Industry-sponsored)
• Locations: 3 sites (Chandler, Arizona and 2 other locations)
• Trial ID: NCT07219550 on ClinicalTrials.gov

What this trial studies

This Phase 1 study compares the pharmacokinetics and safety of calderasib in adults with chronic, stable hepatic impairment and in medically healthy volunteers. Participants meeting BMI and other eligibility criteria will receive calderasib and have blood samples taken over time to measure drug levels and monitor safety. The hepatic impairment group will include people with features of cirrhosis but without recent severe complications, while healthy volunteers must have no clinically significant medical history. Safety monitoring will include clinical assessments and laboratory tests, and participants with recent major surgery, active malignancy, HIV, or significant GI absorption issues are excluded.

Who should consider this trial

Good fit: Ideal candidates are adults with chronic, stable hepatic insufficiency (features of cirrhosis) or medically healthy adults, both with BMI between 18.0 and 42.0 kg/m2 who meet other health criteria.

Not a fit: People with recent severe liver complications, recent variceal bleeding, hepatorenal syndrome, active cancer, HIV, significant GI absorption disorders, or recent major surgery/blood loss are not suitable and are unlikely to benefit from joining this study.

Why it matters

Potential benefit: If successful, the results could show whether people with liver impairment need different dosing or can safely take calderasib, informing safer use in that population.

How similar studies have performed: Comparing drug levels and safety between hepatic impairment groups and healthy volunteers is a well-established method used in drug development to guide dosing, and many approved drugs have dosing recommendations based on similar studies.

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

Where this trial is running

Chandler, Arizona and 2 other locations

• Arizona Clinical Trials ( Site 0003) — Chandler, Arizona, United States (Recruiting)
• Orlando Clinical Research Center ( Site 0001) — Orlando, Florida, United States (Recruiting)
• The Texas Liver Institute ( Site 0002) — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Toll Free Number

Conditions Healthy; Hepatic Impairment