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)

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06619314

Enrollment

Registered

2024-10-01

Start date

2023-09-20

Completion date

2023-11-25

Last updated

2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGCalderasib

Oral Tablet

DRUGPPI

Oral Capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Formulation Effect: Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of Calderasib	At designated timepoints (up to 24 hours postdose)	Blood samples will be collected to determine the AUC0-24 of calderasib.
Formulation Effect: Cmax of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the Cmax of calderasib.
Formulation Effect: Plasma Concentration at 24 hours (C24) of Calderasib	24 hours postdose	Blood samples will be collected to determine the C24 of calderasib.
Formulation Effect: Lag Time (tlag) of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the tlag of calderasib.
Formulation Effect: Time to Maximum Plasma Concentration (Tmax) of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the Tmax of calderasib.
Formulation Effect: Apparent Terminal Half-Life (t1/2) of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the t1/2 of calderasib.
Formulation Effect: Apparent Clearance (CL/F) of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the CL/F of calderasib.
Formulation Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the Vz/F of calderasib.
Proton Pump Inhibitor (PPI) Effect: AUC0-inf of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the AUC0-inf of calderasib.
PPI Effect: Cmax of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the Cmax of calderasib.
Food effect: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the AUC0-inf of calderasib.
Food Effect: Maximum Plasma Concentration (Cmax) of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the Cmax of calderasib.
Formulation Effect: Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the AUC0-last of calderasib.
Formulation Effect: AUC0-inf of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the AUC0-inf of calderasib.

Secondary

Measure	Time frame	Description
PPI Effect: C24 of Calderasib	24 hours postdose	Blood samples will be collected to determine the C24 of calderasib.
PPI Effect: tlag of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the tlag of calderasib.
PPI Effect: Tmax of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the Tmax of calderasib.
PPI Effect: t1/2 of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the t1/2 of calderasib.
PPI Effect: CL/F of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the CL/F of calderasib.
PPI Effect: Vz/F of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the Vz/F of calderasib.
PPI Effect: Number of Participants Who Experience a TEAE	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.
PPI Effect: AUC0-last of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the AUC0-last of calderasib.
PPI Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE	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.
Food Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE	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.
Formulation Effect: Number of Participants Who Experience a TEAE	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.
Formulation Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE	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.
Food Effect: AUC0-last of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the AUC0-last of calderasib.
Food Effect: AUC0-24 of Calderasib	At designated timepoints (up to 24 hours postdose)	Blood samples will be collected to determine the AUC0-24 of calderasib.
Food Effect: C24 of Calderasib	24 hours postdose	Blood samples will be collected to determine the C24 of calderasib.
Food Effect: tlag of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the tlag of calderasib.
Food Effect: Tmax of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the Tmax of calderasib.
Food Effect: t1/2 of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the t1/2 of calderasib.
Food Effect: CL/F of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the CL/F of calderasib.
Food Effect: Vz/F of Calderasib	At designated timepoints (up to 48 hours postdose)	Blood samples will be collected to determine the Vz/F of calderasib.
Food Effect: Number of Participants Who Experience a Treatment Emergent Adverse Event (TEAE)	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.
PPI Effect: AUC0-24 of Calderasib	At designated timepoints (up to 24 hours postdose)	Blood samples will be collected to determine the AUC0-24 of calderasib.

Countries

United States

Contacts

STUDY_DIRECTORMedical Director

Merck Sharp & Dohme LLC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026