A Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor (PPI) on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-003)

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06619314
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Calderasib — DRUG
    Oral Tablet
  • PPI — DRUG
    Oral Capsule

Study Details

The purpose of this study is to evaluate the effect of food, formulation, and a PPI on the levels of calderasib in a person's body over time.

Key Dates

Start date
Sep 20, 2023
Status verified
Feb 2026
Primary completion
Nov 25, 2023
Completion
Nov 25, 2023

Study Design

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

Arms

  • Experimental: Calderasib Treatment A
    Participants will receive calderasib on Day 1 on an empty stomach
  • Experimental: Calderasib Treatment B
    Participants will receive calderasib on Day 1 after a high-fat/high-calorie breakfast
  • Experimental: Calderasib Treatment C
    Participants will receive calderasib Formulation 1 on Day 1
  • Experimental: Calderasib Treatment D
    Participants will receive calderasib Formulation 2 on Day 1
  • Experimental: Calderasib Treatment E
    Participants will receive calderasib without a PPI on Day 1
  • Experimental: Calderasib Treatment F
    Participants will receive calderasib with a PPI on Day 5

Primary Outcome Measure

Food effect: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Calderasib [ Time Frame: At designated timepoints (up to 48 hours postdose) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion (Site 0001)LincolnNebraska68502-

Find similar trials in Lincoln, NE

By research site
Celerion· Lincoln, NE

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