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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06942741
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
May 13, 2025
Status verified
Feb 2026
Primary completion
Jun 22, 2025
Completion
Aug 4, 2025

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part 1 Calderasib Treatment A
    Participants will be administered low dose calderasib as an oral-compressed tablet (OCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)
  • Experimental: Part 1 Calderasib Treatment B
    Participants will be administered low dose calderasib as a film-coated tablet (FCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)
  • Experimental: Part 2 Calderasib Treatment C
    Participants will be administered higher dose calderasib as a FCT on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)
  • Experimental: Part 2 Calderasib Treatment D
    Participants will be administered higher dose calderasib as a FCT on Day 1 under fed conditions (after a high-fat meal)

Primary Outcome Measure

Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Calderasib [ Time Frame: At designated timepoints (up to approximately 2 days postdose) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion ( Site 0001)TempeArizona85283-

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By research site
Celerion· Tempe, AZ

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