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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07219550
Phase
PHASE1
Status
Recruiting

Conditions

  • Healthy
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 5, 2025
Status verified
Mar 2026
Primary completion
Aug 7, 2026
Completion
Aug 14, 2026

Study Design

Enrollment
58 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Calderasib
    All participants will receive a single oral dose of calderasib on Day 1.

Primary Outcome Measure

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Arizona Clinical Trials ( Site 0003)ChandlerArizona85225
Study Coordinator
210-253-3426
Orlando Clinical Research Center ( Site 0001)OrlandoFlorida32809
Study Coordinator
407-240-7878
The Texas Liver Institute ( Site 0002)San AntonioTexas78215
Study Coordinator
480-470-4000

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