NCT07219550

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Calderasib	Oral Tablet

Timeline

• Start date: 2025-11-05
• Primary completion: 2026-08-07
• Completion: 2026-08-14
• First posted: 2025-10-22
• Last updated: 2026-03-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study