CompletedPhase 1

A Study to Evaluate the Effect of Formulation and Food on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-011)

United States52 participantsStarted 2025-05-13

Plain-language summary

This study has 2 parts. Researchers want to learn what happens to calderasib in a healthy person's body over time in both parts. The goals of the study are: * In Part 1, to compare what happens to calderasib in a person's blood when it is taken as 2 different types of oral tablets * In Part 2, to learn what happens to calderasib in a person's blood when it is taken on an empty stomach or after a meal

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion Criteria: The main inclusion criteria include but are not limited to the following: \- Has a body mass index ≥18.0 and ≤32.0 kg/m\^2 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history or presence of a clinically significant medical or psychiatric condition or disease * Has a history of cancer (malignancy) * Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus

What they're measuring

Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Calderasib

Timeframe: At designated timepoints (up to approximately 2 days postdose)

Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Calderasib

Timeframe: At designated timepoints (up to approximately 2 days postdose)

Parts 1 and 2: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of Calderasib

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

Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Calderasib

Timeframe: At designated timepoints (up to approximately 2 days postdose)

Parts 1 and 2: Plasma Concentration of Calderasib at 24 Hours Postdose (C24)

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

Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of Calderasib

Timeframe: At designated timepoints (up to approximately 2 days postdose)

Parts 1 and 2: Apparent Terminal Half-life (t1/2) of Calderasib

Trial details

NCT IDNCT06942741

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-22

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