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

NCT07219550 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 1084-017MK-1084-017
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Healthy; Hepatic Impairment

Outcome Measures

Primary Outcomes (8)

• Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib

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

  At designated timepoints up to approximately 7 days post-dose

• Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Calderasib

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

  At designated timepoints up to approximately 7 days post-dose

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

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

  Up to approximately 24 hours post-dose

• Maximum Observed Drug Concentration (Cmax) of Calderasib

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

  At designated timepoints up to approximately 7 days post-dose

• Time to Maximum Observed Drug Concentration (Tmax) of Calderasib

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

  At designated timepoints up to approximately 7 days post-dose

• Apparent Terminal Half-life (t1/2) of Calderasib

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

  At designated timepoints up to approximately 7 days post-dose

• Apparent Clearance (CL/F) of Calderasib

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

  At designated timepoints up to approximately 7 days post-dose

• Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib

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

  At designated timepoints up to approximately 7 days post-dose

Secondary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 14 days

• Number of Participants Who Discontinue Study Due to an AE

  Up to approximately 14 days

Study Arms (1)

Calderasib

EXPERIMENTAL

All participants will receive a single oral dose of calderasib on Day 1.

Drug: Calderasib

Interventions

Calderasib DRUG

Oral Tablet

Also known as: MK-1084

Calderasib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (3)

Arizona Clinical Trials ( Site 0003)

Chandler, Arizona, 85225, United States

RECRUITING

Orlando Clinical Research Center ( Site 0001)

Orlando, Florida, 32809, United States

RECRUITING

The Texas Liver Institute ( Site 0002)

San Antonio, Texas, 78215, United States

RECRUITING

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 22, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): August 7, 2026
• Study Completion (Estimated): August 14, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (3)