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)

NCT06619314 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1084-003MK-1084-003
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (14)

• 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.

  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.

  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.

  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.

  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.

  At designated timepoints (up to 24 hours postdose)

• Formulation Effect: Cmax of Calderasib

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

  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.

  24 hours postdose

• Formulation Effect: Lag Time (tlag) of Calderasib

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

  At designated timepoints (up to 48 hours postdose)

• Formulation Effect: Time to Maximum Plasma Concentration (Tmax) of Calderasib

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

  At designated timepoints (up to 48 hours postdose)

• Formulation Effect: Apparent Terminal Half-Life (t1/2) of Calderasib

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

  At designated timepoints (up to 48 hours postdose)

• Formulation Effect: Apparent Clearance (CL/F) of Calderasib

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

  At designated timepoints (up to 48 hours postdose)

• Formulation Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib

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

  At designated timepoints (up to 48 hours postdose)

• Proton Pump Inhibitor (PPI) Effect: AUC0-inf of Calderasib

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

  At designated timepoints (up to 48 hours postdose)

• PPI Effect: Cmax of Calderasib

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

  At designated timepoints (up to 48 hours postdose)

Secondary Outcomes (22)

• Food Effect: AUC0-last of Calderasib

  At designated timepoints (up to 48 hours postdose)

• Food Effect: AUC0-24 of Calderasib

  At designated timepoints (up to 24 hours postdose)

• Food Effect: C24 of Calderasib

  24 hours postdose

• Food Effect: tlag of Calderasib

  At designated timepoints (up to 48 hours postdose)

• Food Effect: Tmax of Calderasib

  At designated timepoints (up to 48 hours postdose)

Study Arms (6)

Calderasib Treatment A

EXPERIMENTAL

Participants will receive calderasib on Day 1 on an empty stomach

Drug: Calderasib

Calderasib Treatment B

EXPERIMENTAL

Participants will receive calderasib on Day 1 after a high-fat/high-calorie breakfast

Drug: Calderasib

Calderasib Treatment C

EXPERIMENTAL

Participants will receive calderasib Formulation 1 on Day 1

Drug: Calderasib

Calderasib Treatment D

EXPERIMENTAL

Participants will receive calderasib Formulation 2 on Day 1

Drug: Calderasib

Calderasib Treatment E

EXPERIMENTAL

Participants will receive calderasib without a PPI on Day 1

Drug: Calderasib

Calderasib Treatment F

EXPERIMENTAL

Participants will receive calderasib with a PPI on Day 5

Drug: Calderasib; Drug: PPI

Interventions

Calderasib DRUG

Oral Tablet

Also known as: MK-1084

Calderasib Treatment A; Calderasib Treatment B; Calderasib Treatment C; Calderasib Treatment D; Calderasib Treatment E; Calderasib Treatment F

PPI DRUG

Oral Capsule

Calderasib Treatment F

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Has a history of cancer.
• Has had major surgery and/or donated or lost significant volume of blood.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: September 20, 2023
• Primary Completion: November 25, 2023
• Study Completion: November 25, 2023
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)