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Liver function may change how this drug works – new study recruiting

NCT ID NCT07219550

Knowledge-focused Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study looks at how the drug MK-1084 (calderasib) moves through the body in people with and without liver problems. Researchers will measure drug levels in the blood and check for side effects. About 58 adults will take a single dose and be monitored. The goal is to understand if liver impairment changes how the drug is processed, which helps doctors decide on safe dosing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

32 people

The number who actually took part.

Started

Nov 2025

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

liver disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy Hepatic impairment

Contacts and locations

Locations

  • Arizona Clinical Trials ( Site 0003)

    Chandler, Arizona, 85225, United States

  • Orlando Clinical Research Center ( Site 0001)

    Orlando, Florida, 32809, United States

  • The Texas Liver Institute ( Site 0002)

    San Antonio, Texas, 78215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.