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)

February 9, 2026 updated by: Merck Sharp & Dohme LLC

A Three-Part Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor on the Single-Dose Pharmacokinetics of MK-1084 in Healthy Adult Participants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion (Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
  • Medically healthy with no clinically significant medical history.

Exclusion Criteria:

  • Has a history of cancer.
  • Has had major surgery and/or donated or lost significant volume of blood.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calderasib Treatment A
Participants will receive calderasib on Day 1 on an empty stomach
Drug: Calderasib
Oral Tablet
Other Names:
  • MK-1084
Experimental: Calderasib Treatment B
Participants will receive calderasib on Day 1 after a high-fat/high-calorie breakfast
Drug: Calderasib
Oral Tablet
Other Names:
  • MK-1084
Experimental: Calderasib Treatment C
Participants will receive calderasib Formulation 1 on Day 1
Drug: Calderasib
Oral Tablet
Other Names:
  • MK-1084
Experimental: Calderasib Treatment D
Participants will receive calderasib Formulation 2 on Day 1
Drug: Calderasib
Oral Tablet
Other Names:
  • MK-1084
Experimental: Calderasib Treatment E
Participants will receive calderasib without a PPI on Day 1
Drug: Calderasib
Oral Tablet
Other Names:
  • MK-1084
Experimental: Calderasib Treatment F
Participants will receive calderasib with a PPI on Day 5
Drug: PPI
Oral Capsule
Drug: Calderasib
Oral Tablet
Other Names:
  • MK-1084

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Blood samples will be collected to determine the AUC0-inf of calderasib.
At designated timepoints (up to 48 hours postdose)
Food Effect: Maximum Plasma Concentration (Cmax) of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Cmax of calderasib.
At designated timepoints (up to 48 hours postdose)
Formulation Effect: Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the AUC0-last of calderasib.
At designated timepoints (up to 48 hours postdose)
Formulation Effect: AUC0-inf of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the AUC0-inf of calderasib.
At designated timepoints (up to 48 hours postdose)
Formulation Effect: Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of Calderasib
Time Frame: At designated timepoints (up to 24 hours postdose)
Blood samples will be collected to determine the AUC0-24 of calderasib.
At designated timepoints (up to 24 hours postdose)
Formulation Effect: Cmax of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Cmax of calderasib.
At designated timepoints (up to 48 hours postdose)
Formulation Effect: Plasma Concentration at 24 hours (C24) of Calderasib
Time Frame: 24 hours postdose
Blood samples will be collected to determine the C24 of calderasib.
24 hours postdose
Formulation Effect: Lag Time (tlag) of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the tlag of calderasib.
At designated timepoints (up to 48 hours postdose)
Formulation Effect: Time to Maximum Plasma Concentration (Tmax) of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Tmax of calderasib.
At designated timepoints (up to 48 hours postdose)
Formulation Effect: Apparent Terminal Half-Life (t1/2) of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the t1/2 of calderasib.
At designated timepoints (up to 48 hours postdose)
Formulation Effect: Apparent Clearance (CL/F) of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the CL/F of calderasib.
At designated timepoints (up to 48 hours postdose)
Formulation Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Vz/F of calderasib.
At designated timepoints (up to 48 hours postdose)
Proton Pump Inhibitor (PPI) Effect: AUC0-inf of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the AUC0-inf of calderasib.
At designated timepoints (up to 48 hours postdose)
PPI Effect: Cmax of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Cmax of calderasib.
At designated timepoints (up to 48 hours postdose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Effect: Number of Participants Who Experience a Treatment Emergent Adverse Event (TEAE)
Time Frame: Up to approximately 2 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 2 months
Food Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE
Time Frame: Up to approximately 2 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 2 months
Formulation Effect: Number of Participants Who Experience a TEAE
Time Frame: Up to approximately 2 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 2 months
Formulation Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE
Time Frame: Up to approximately 2 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 2 months
PPI Effect: Number of Participants Who Experience a TEAE
Time Frame: Up to approximately 2 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 2 months
PPI Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE
Time Frame: Up to approximately 2 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 2 months
Food Effect: AUC0-last of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the AUC0-last of calderasib.
At designated timepoints (up to 48 hours postdose)
Food Effect: AUC0-24 of Calderasib
Time Frame: At designated timepoints (up to 24 hours postdose)
Blood samples will be collected to determine the AUC0-24 of calderasib.
At designated timepoints (up to 24 hours postdose)
Food Effect: C24 of Calderasib
Time Frame: 24 hours postdose
Blood samples will be collected to determine the C24 of calderasib.
24 hours postdose
Food Effect: tlag of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the tlag of calderasib.
At designated timepoints (up to 48 hours postdose)
Food Effect: Tmax of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Tmax of calderasib.
At designated timepoints (up to 48 hours postdose)
Food Effect: t1/2 of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the t1/2 of calderasib.
At designated timepoints (up to 48 hours postdose)
Food Effect: CL/F of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the CL/F of calderasib.
At designated timepoints (up to 48 hours postdose)
Food Effect: Vz/F of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Vz/F of calderasib.
At designated timepoints (up to 48 hours postdose)
PPI Effect: AUC0-last of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the AUC0-last of calderasib.
At designated timepoints (up to 48 hours postdose)
PPI Effect: AUC0-24 of Calderasib
Time Frame: At designated timepoints (up to 24 hours postdose)
Blood samples will be collected to determine the AUC0-24 of calderasib.
At designated timepoints (up to 24 hours postdose)
PPI Effect: C24 of Calderasib
Time Frame: 24 hours postdose
Blood samples will be collected to determine the C24 of calderasib.
24 hours postdose
PPI Effect: tlag of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the tlag of calderasib.
At designated timepoints (up to 48 hours postdose)
PPI Effect: Tmax of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Tmax of calderasib.
At designated timepoints (up to 48 hours postdose)
PPI Effect: t1/2 of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the t1/2 of calderasib.
At designated timepoints (up to 48 hours postdose)
PPI Effect: CL/F of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the CL/F of calderasib.
At designated timepoints (up to 48 hours postdose)
PPI Effect: Vz/F of Calderasib
Time Frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Vz/F of calderasib.
At designated timepoints (up to 48 hours postdose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Actual)

November 25, 2023

Study Completion (Actual)

November 25, 2023

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 1084-003
  • MK-1084-003 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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