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
- Calderasib — DRUGOral Tablet
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: CalderasibAll 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
- Toll Free Number1-888-577-8839
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arizona Clinical Trials ( Site 0003) | Chandler | Arizona | 85225 | Study Coordinator 210-253-3426 |
| Orlando Clinical Research Center ( Site 0001) | Orlando | Florida | 32809 | Study Coordinator 407-240-7878 |
| The Texas Liver Institute ( Site 0002) | San Antonio | Texas | 78215 | Study Coordinator 480-470-4000 |
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