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OpenTrials
Completed

NCT Number: NCT06687759

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortea CRU Madison (Site 0001)

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[14C]Calderasib

Drug

Oral administration

Other names: MK-1084

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. 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.

  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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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