CompletedPhase 1

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)

United States56 participantsStarted 2023-09-20

Plain-language 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.

Who can participate

Age range19 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: At designated timepoints (up to 48 hours postdose)

Food Effect: Maximum Plasma Concentration (Cmax) of Calderasib

Timeframe: 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

Timeframe: At designated timepoints (up to 48 hours postdose)

Formulation Effect: AUC0-inf of Calderasib

Timeframe: 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

Timeframe: At designated timepoints (up to 24 hours postdose)

Formulation Effect: Cmax of Calderasib

Timeframe: At designated timepoints (up to 48 hours postdose)

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

Timeframe: 24 hours postdose

Trial details

NCT IDNCT06619314

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-25

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range19 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: At designated timepoints (up to 48 hours postdose)

Food Effect: Maximum Plasma Concentration (Cmax) of Calderasib

Timeframe: 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

Timeframe: At designated timepoints (up to 48 hours postdose)

Formulation Effect: AUC0-inf of Calderasib

Timeframe: 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

Timeframe: At designated timepoints (up to 24 hours postdose)

Formulation Effect: Cmax of Calderasib

Timeframe: At designated timepoints (up to 48 hours postdose)

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

Timeframe: 24 hours postdose