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Completed

NCT Number: NCT06619314

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)

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.

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Calderasib

Drug

Oral Tablet

Other names: MK-1084

PPI

Drug

Oral Capsule

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Food Effect: C24 of Calderasib

    Time frame: 24 hours postdose

    Blood samples will be collected to determine the C24 of calderasib.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. PPI Effect: C24 of Calderasib

    Time frame: 24 hours postdose

    Blood samples will be collected to determine the C24 of calderasib.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 1, 2024
Registry last updated
Feb 11, 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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