NCT06942741

A Study to Evaluate the Effect of Formulation and Food on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-011)

A Two-Part Study to Determine Bioequivalence Between the MK-1084 Film-Coated Tablet and Oral-Compressed Tablet and the Effect of Food on the Single-Dose Pharmacokinetics of the MK-1084 Film-Coated Tablet in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study has 2 parts. Researchers want to learn what happens to calderasib in a healthy person's body over time in both parts. The goals of the study are: * In Part 1, to compare what happens to calderasib in a person's blood when it is taken as 2 different types of oral tablets * In Part 2, to learn what happens to calderasib in a person's blood when it is taken on an empty stomach or after a meal

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Calderasib OCT	Oral tablet
DRUG	Calderasib FCT	Oral tablet

Timeline

• Start date: 2025-05-13
• Primary completion: 2025-06-22
• Completion: 2025-08-04
• First posted: 2025-04-24
• Last updated: 2026-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study