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)

Phase 1CompletedNCT06619314

Merck Sharp & Dohme LLC56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

CalderasibDRUG

Oral Tablet

PPIDRUG

Oral Capsule

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Celerion (Site 0001)

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Food effect: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Calderasib

Blood samples will be collected to determine the AUC0-inf of calderasib.

Time frame: At designated timepoints (up to 48 hours postdose)

Food Effect: Maximum Plasma Concentration (Cmax) of Calderasib

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

Time frame: At designated timepoints (up to 48 hours postdose)

Formulation Effect: Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib

Blood samples will be collected to determine the AUC0-last of calderasib.

Time frame: At designated timepoints (up to 48 hours postdose)

Formulation Effect: AUC0-inf of Calderasib

Blood samples will be collected to determine the AUC0-inf of calderasib.

Time frame: At designated timepoints (up to 48 hours postdose)

Formulation Effect: Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of Calderasib

Blood samples will be collected to determine the AUC0-24 of calderasib.

Time frame: At designated timepoints (up to 24 hours postdose)

Formulation Effect: Cmax of Calderasib

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

Time frame: At designated timepoints (up to 48 hours postdose)

Formulation Effect: Plasma Concentration at 24 hours (C24) of Calderasib

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

Time frame: 24 hours postdose

Data from ClinicalTrials.gov

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Secondary Outcomes

Food Effect: AUC0-last of Calderasib

Blood samples will be collected to determine the AUC0-last of calderasib.

Time frame: At designated timepoints (up to 48 hours postdose)

Food Effect: AUC0-24 of Calderasib

Blood samples will be collected to determine the AUC0-24 of calderasib.

Time frame: At designated timepoints (up to 24 hours postdose)

Food Effect: C24 of Calderasib

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

Time frame: 24 hours postdose

Food Effect: tlag of Calderasib

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

Time frame: At designated timepoints (up to 48 hours postdose)

Food Effect: Tmax of Calderasib

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

Time frame: At designated timepoints (up to 48 hours postdose)

Food Effect: t1/2 of Calderasib

Blood samples will be collected to determine the t1/2 of calderasib.

Time frame: At designated timepoints (up to 48 hours postdose)

Food Effect: CL/F of Calderasib

Blood samples will be collected to determine the CL/F of calderasib.

Time frame: At designated timepoints (up to 48 hours postdose)

Food Effect: Vz/F of Calderasib

Blood samples will be collected to determine the Vz/F of calderasib.

Time frame: At designated timepoints (up to 48 hours postdose)

Food Effect: Number of Participants Who Experience a Treatment Emergent Adverse Event (TEAE)

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.

Time frame: Up to approximately 2 months

Food Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE

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.

Time frame: Up to approximately 2 months

Formulation Effect: Number of Participants Who Experience a TEAE

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.

Time frame: Up to approximately 2 months

Formulation Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE

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.

Time frame: Up to approximately 2 months

PPI Effect: AUC0-last of Calderasib

Blood samples will be collected to determine the AUC0-last of calderasib.

Time frame: At designated timepoints (up to 48 hours postdose)

PPI Effect: AUC0-24 of Calderasib

Blood samples will be collected to determine the AUC0-24 of calderasib.

Time frame: At designated timepoints (up to 24 hours postdose)

PPI Effect: C24 of Calderasib

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

Time frame: 24 hours postdose

PPI Effect: tlag of Calderasib

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

Time frame: At designated timepoints (up to 48 hours postdose)

PPI Effect: Tmax of Calderasib

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

Time frame: At designated timepoints (up to 48 hours postdose)

PPI Effect: t1/2 of Calderasib

Blood samples will be collected to determine the t1/2 of calderasib.

Time frame: At designated timepoints (up to 48 hours postdose)

PPI Effect: CL/F of Calderasib

Blood samples will be collected to determine the CL/F of calderasib.

Time frame: At designated timepoints (up to 48 hours postdose)

PPI Effect: Vz/F of Calderasib

Blood samples will be collected to determine the Vz/F of calderasib.

Time frame: At designated timepoints (up to 48 hours postdose)

PPI Effect: Number of Participants Who Experience a TEAE

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.

Time frame: Up to approximately 2 months

PPI Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE

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.

Time frame: Up to approximately 2 months