A Clinical Study of Calderasib (MK-1084) With Rosuvastatin and Metformin in Healthy People (MK-1084-016)

NCT07222098 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1084-016MK-1084-016
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers want to learn about calderasib when given with rosuvastatin and metformin in healthy people. The goal of this study is to compare the amount of rosuvastatin and metformin in a person's body over time when given with and without calderasib

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Rosuvastatin

  Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin

  Day 1: Predose and at designated timepoints up to 120 hours post-dose

• Maximum Plasma Concentration (Cmax) of Rosuvastatin

  Blood samples will be collected at multiple time points to determine the Cmax of rosuvastatin

  Day 1: Predose and at designated timepoints up to 120 hours post-dose

• AUC0-inf of Metformin

  Blood samples will be collected at multiple time points to determine the AUC0-inf of metformin

  Day 1: Predose and at designated timepoints up to 72 hours post-dose

Secondary Outcomes (27)

• Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Rosuvastatin

  Day 1: Predose and at designated timepoints up to 120 hours post-dose

• Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of Rosuvastatin

  Day 1: Predose and at designated timepoints up to 24 hours post-dose

• Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin

  Day 1: Predose and at designated timepoints up to 120 hours post-dose

• Day 1: Apparent Terminal Half-life (t1/2) of Rosuvastatin

  Day 1: Predose and at designated timepoints up to 120 hours post-dose

• Apparent Clearance (CL/F) of Rosuvastatin

  Day 1: Predose and at designated timepoints up to 120 hours post-dose

Study Arms (2)

Rosuvastatin + metformin

EXPERIMENTAL

Participants will receive rosuvastatin plus metformin

Drug: Rosuvastatin; Drug: Metformin

Rosuvastatin + metformin + Calderasib

EXPERIMENTAL

Participants will receive rosuvastatin plus metformin plus calderasib

Drug: Rosuvastatin; Drug: Metformin; Drug: Calderasib

Interventions

Rosuvastatin DRUG

Oral tablet

Rosuvastatin + metformin; Rosuvastatin + metformin + Calderasib

Metformin DRUG

Oral tablet

Rosuvastatin + metformin; Rosuvastatin + metformin + Calderasib

Calderasib DRUG

Oral tablet

Also known as: MK-1084

Rosuvastatin + metformin + Calderasib

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Has history of cancer (malignancy)
• Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

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

MeSH Terms

Interventions

Rosuvastatin Calcium; Metformin

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

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: October 27, 2025
• First Posted: October 29, 2025
• Study Start: November 19, 2025
• Primary Completion: December 14, 2025
• Study Completion: December 23, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)