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

NCT06942741 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1084-011MK-1084-011
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (10)

• 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

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

  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

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

  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

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

  At designated timepoints (up to 24 hours postdose)

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

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

  At designated timepoints (up to approximately 2 days postdose)

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

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

  At designated timepoints (up to 24 hours postdose)

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

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

  At designated timepoints (up to approximately 2 days postdose)

• Parts 1 and 2: 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 approximately 2 days postdose)

• Parts 1 and 2: Apparent Clearance (CL/F) of Calderasib

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

  At designated timepoints (up to approximately 2 days postdose)

• Parts 1 and 2: 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 approximately 2 days postdose)

• Part 2: Plasma Lag Time (tlag) of Calderasib

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

  At designated timepoints (up to approximately 2 days postdose)

Secondary Outcomes (2)

• Parts 1 and 2: Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 7 weeks

• Parts 1 and 2: Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 1 week

Study Arms (4)

Part 1 Calderasib Treatment A

EXPERIMENTAL

Participants will be administered low dose calderasib as an oral-compressed tablet (OCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)

Drug: Calderasib OCT

Part 1 Calderasib Treatment B

EXPERIMENTAL

Participants will be administered low dose calderasib as a film-coated tablet (FCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)

Drug: Calderasib FCT

Part 2 Calderasib Treatment C

EXPERIMENTAL

Participants will be administered higher dose calderasib as a FCT on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)

Drug: Calderasib FCT

Part 2 Calderasib Treatment D

EXPERIMENTAL

Participants will be administered higher dose calderasib as a FCT on Day 1 under fed conditions (after a high-fat meal)

Drug: Calderasib FCT

Interventions

Calderasib OCT DRUG

Oral tablet

Also known as: MK-1084 OCT

Part 1 Calderasib Treatment A

Calderasib FCT DRUG

Oral tablet

Also known as: MK-1084 FCT

Part 1 Calderasib Treatment B; Part 2 Calderasib Treatment C; Part 2 Calderasib Treatment D

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Has a body mass index ≥18.0 and ≤32.0 kg/m\^2

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion ( Site 0001)

Tempe, Arizona, 85283, 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: April 17, 2025
• First Posted: April 24, 2025
• Study Start: May 13, 2025
• Primary Completion: June 22, 2025
• Study Completion: August 4, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)