NCT06814119

A Clinical Study of Calderasib (MK-1084) in Participants With Renal Impairment (MK-1084-010)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The goal 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 people with moderate or severe renal impairment (RI) (meaning the kidneys do not work properly) as compared to people who are in good health. Researchers also want to learn about the safety of calderasib when it is given to people with RI and if people with RI can tolerate it.

Conditions

• Healthy
• Renal Impairment

Interventions

Type	Name	Description
DRUG	Calderasib	Oral tablet

Timeline

• Start date: 2025-04-07
• Primary completion: 2026-01-23
• Completion: 2026-02-06
• First posted: 2025-02-07
• Last updated: 2026-02-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study