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

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

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

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
    • Arizona
      • Tempe, Arizona, United States, 85283
        • 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:

The main inclusion criteria include but are not limited to the following:

- Has a body mass index ≥18.0 and ≤32.0 kg/m^2

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has a history or presence of a clinically significant medical or psychiatric condition or disease
  • Has a history of cancer (malignancy)
  • Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus

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: 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)
Drug: Calderasib OCT
Oral tablet
Other Names:
  • MK-1084 OCT
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)
Drug: Calderasib FCT
Oral tablet
Other Names:
  • MK-1084 FCT
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)
Drug: Calderasib FCT
Oral tablet
Other Names:
  • MK-1084 FCT
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)
Drug: Calderasib FCT
Oral tablet
Other Names:
  • MK-1084 FCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Blood samples will be collected to determine the AUC0-last of calderasib.
At designated timepoints (up to approximately 2 days postdose)
Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Calderasib
Time Frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the AUC0-inf of calderasib.
At designated timepoints (up to approximately 2 days postdose)
Parts 1 and 2: Area Under the Concentration-Time Curve from Time 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)
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Calderasib
Time Frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the Cmax of calderasib.
At designated timepoints (up to approximately 2 days postdose)
Parts 1 and 2: Plasma Concentration of Calderasib at 24 Hours Postdose (C24)
Time Frame: At designated timepoints (up to 24 hours postdose)
Blood samples will be collected to determine the C24 of calderasib.
At designated timepoints (up to 24 hours postdose)
Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of Calderasib
Time Frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the Tmax of calderasib.
At designated timepoints (up to approximately 2 days postdose)
Parts 1 and 2: Apparent Terminal Half-life (t1/2) of Calderasib
Time Frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the t1/2 of calderasib.
At designated timepoints (up to approximately 2 days postdose)
Parts 1 and 2: Apparent Clearance (CL/F) of Calderasib
Time Frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the CL/F of calderasib.
At designated timepoints (up to approximately 2 days postdose)
Parts 1 and 2: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib
Time Frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the Vz/F of calderasib.
At designated timepoints (up to approximately 2 days postdose)
Part 2: Plasma Lag Time (tlag) of Calderasib
Time Frame: At designated timepoints (up to approximately 2 days postdose)
Blood samples will be collected to determine the tlag of calderasib.
At designated timepoints (up to approximately 2 days postdose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parts 1 and 2: Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 7 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported
Up to approximately 7 weeks
Parts 1 and 2: Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 1 week
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue from the study treatment due to an AE will be reported.
Up to approximately 1 week

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)

May 13, 2025

Primary Completion (Actual)

June 22, 2025

Study Completion (Actual)

August 4, 2025

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 24, 2025

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

  • 1084-011
  • MK-1084-011 (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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