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

NCT06687759 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1084-006MK-1084-006
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (21)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of plasma Calderasib

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Urine samples will be collected to determine the Aeu of calderasib

  Predose and at designated timepoints up to Day 15

• Cumulative Aeu of Calderasib

  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

  Urine samples will be collected to determine the feu of calderasib.

  Predose and at designated timepoints up to Day 15

• Cumulative feu of Calderasib

  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

  Feces samples will be collected to determine the Aef of calderasib.

  Predose and at designated timepoints up to Day 15

• Cumulative Aef of Calderasib

  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

  Feces samples will be collected to determine the fef of calderasib.

  Predose and at designated timepoints up to Day 15

• Cumulative fef of Calderasib

  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

  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

  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

  Feces samples will be collected to determine the metabolites of calderasib.

  Predose and at designated timepoints up to Day 15

Secondary Outcomes (2)

• Number of Participants Experiencing an Adverse Event (AE)

  Up to ~ 28 days

• Number of Participants Discontinuing Study Treatment due to an AE

  Up to ~ 28 days

Study Arms (1)

Carbon-14 radiolabeled [14C] MK-1084

EXPERIMENTAL

Participants receive single oral dose of calderasib on Day 1.

Drug: [14C]Calderasib

Interventions

[14C]Calderasib DRUG

Oral administration

Also known as: MK-1084

Carbon-14 radiolabeled [14C] MK-1084

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Fortea CRU Madison (Site 0001)

Madison, Wisconsin, 53704, United States

Location

Related Links

• Merck Clinical Trials Information

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: June 26, 2024
• Primary Completion: August 7, 2024
• Study Completion: August 7, 2024
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)