A Study of Calderasib (MK-1084) Human Absorption, Distribution, Metabolism, and Excretion in Healthy Adult Participants (MK-1084-006)

April 8, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 1 Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]MK-1084 in Healthy Adult Participants

The purpose of this study is to learn what happens to calderasib in a healthy person's body over time and how it is cleared from the body.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

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
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Fortea CRU Madison (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:

Key inclusion criteria include but are not limited to the following:

  • Is in good health based on medical history, physical examination,vital signs measurements, and electrocardiogram (ECG)s performed before randomization.
  • Has a body mass index (BMI) 18 to 32 kg/m2, inclusive, at screening

Exclusion Criteria:

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

  • Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
  • Has a history of cancer.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carbon-14 radiolabeled [14C] MK-1084
Participants receive single oral dose of calderasib on Day 1.
Drug: [14C]Calderasib
Oral administration
Other Names:
  • MK-1084

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of plasma Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Bood samples will be collected to determine the AUC0-inf of calderasib in plasma.
Predose and at designated timepoints up to Day 15
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of plasma Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-last of calderasib in plasma.
Predose and at designated timepoints up to Day 15
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of plasma Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-24 of plasma calderasib in plasma.
Predose and at designated timepoints up to Day 15
Maximum Concentration (Cmax) of plasma Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Cmax of calderasib in plasma.
Predose and at designated timepoints up to Day 15
Concentration at 24 hours postdose (C24) of plasma Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the C24 of calderasib in plasma.
Predose and at designated timepoints up to Day 15
Time to Reach Maximum Concentration (Tmax) of plasma Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Tmax of calderasib in plasma.
Predose and at designated timepoints up to Day 15
Apparent Half Life (t½) of plasma Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the t1/2 of calderasib in plasma.
Predose and at designated timepoints up to Day 15
Apparent Total Clearance (CL/F) of plasma Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the CL/F of calderasib in plasma.
Predose and at designated timepoints up to Day 15
Apparent Volume of Distribution during the Terminal Elimination Phase (Vz/F) of plasma Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Vz/F of calderasib in plasma.
Predose and at designated timepoints up to Day 15
AUC0-inf/Total Radioactivity Ratio of plasma Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-inf/Total Radioactivity Ratio of calderasib in plasma.
Predose and at designated timepoints up to Day 15
Amount Excreted in the Urine (Aeu) of Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the Aeu of calderasib
Predose and at designated timepoints up to Day 15
Cumulative Aeu of Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the cumulative Ae of calderasib.
Predose and at designated timepoints up to Day 15
Percentage Excreted in the Urine (feu) of Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the feu of calderasib.
Predose and at designated timepoints up to Day 15
Cumulative feu of Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the cumulative feu of calderasib.
Predose and at designated timepoints up to Day 15
Amount Excreted in the Feces (Aef) of Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the Aef of calderasib.
Predose and at designated timepoints up to Day 15
Cumulative Aef of Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the cumulative Aef of calderasib.
Predose and at designated timepoints up to Day 15
Percentage Excreted in the Feces (fef) of Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the fef of calderasib.
Predose and at designated timepoints up to Day 15
Cumulative fef of Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the cumulative fef of calderasib.
Predose and at designated timepoints up to Day 15
Metabolites in Plasma of Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the metabolites of calderasib.
Predose and at designated timepoints up to Day 15
Metabolites in Urine of Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the metabolites of calderasib.
Predose and at designated timepoints up to Day 15
Metabolites in Feces of Calderasib
Time Frame: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the metabolites of calderasib.
Predose and at designated timepoints up to Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing an Adverse Event (AE)
Time Frame: Up to ~ 28 days
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.
Up to ~ 28 days
Number of Participants Discontinuing Study Treatment due to an AE
Time Frame: Up to ~ 28 days
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.
Up to ~ 28 days

Collaborators and Investigators

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

Sponsor

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)

June 26, 2024

Primary Completion (Actual)

August 7, 2024

Study Completion (Actual)

August 7, 2024

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 14, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 1084-006
  • MK-1084-006 (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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