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
- Completed
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
- First listed
- Oct 22, 2025
- Start date
- Nov 5, 2025
- Status verified
- Aug 2026
- Primary completion
- Jul 15, 2026
- Completion
- Jul 15, 2026
Study Design
- Enrollment
- 32 participants (actual)
- 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 ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arizona Clinical Trials ( Site 0003) | Chandler | Arizona | 85225 | - |
| Orlando Clinical Research Center ( Site 0001) | Orlando | Florida | 32809 | - |
| The Texas Liver Institute ( Site 0002) | San Antonio | Texas | 78215 | - |
Find similar trials in Chandler, AZ
Related Studies
- Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated DonorsPHASE3 · Recruiting · Center for International Blood and Marrow Transplant Research · Boca Raton, Florida
- The BrainHealth ProjectRecruiting · The University of Texas at Dallas · Dallas, Texas
- Non-invasive BCI-controlled Assistive DevicesRecruiting · University of Texas at Austin · Austin, Texas
- Viral Mucosal ReprogrammingPHASE2 · Recruiting · The University of Texas Medical Branch, Galveston · Galveston, Texas