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NCT Number: NCT07219550

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arizona Clinical Trials ( Site 0003), Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calderasib

Drug

Oral Tablet

Other names: MK-1084

Primary outcomes

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

    Time frame: At designated timepoints up to approximately 7 days post-dose

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

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

    Time frame: At designated timepoints up to approximately 7 days post-dose

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

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

    Time frame: Up to approximately 24 hours post-dose

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

  4. Maximum Observed Drug Concentration (Cmax) of Calderasib

    Time frame: At designated timepoints up to approximately 7 days post-dose

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

  5. Time to Maximum Observed Drug Concentration (Tmax) of Calderasib

    Time frame: At designated timepoints up to approximately 7 days post-dose

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

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

    Time frame: At designated timepoints up to approximately 7 days post-dose

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

  7. Apparent Clearance (CL/F) of Calderasib

    Time frame: At designated timepoints up to approximately 7 days post-dose

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

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

    Time frame: At designated timepoints up to approximately 7 days post-dose

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

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 14 days

    An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants experiencing AEs will be reported.

  2. Number of Participants Who Discontinue Study Due to an AE

    Time frame: Up to approximately 14 days

    An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants discontinuing the study due to AEs will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 22, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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