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

An Open-Label, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of MK-1084 on the Single-Dose Pharmacokinetics of Rosuvastatin and Metformin in Healthy Participants

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Metformin; Drug: Rosuvastatin; Drug: Calderasib

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion ( Site 0001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

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

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rosuvastatin + metformin; Participants will receive rosuvastatin plus metformin	Drug: Metformin; Oral tablet; Drug: Rosuvastatin; Oral tablet
Experimental: Rosuvastatin + metformin + Calderasib; Participants will receive rosuvastatin plus metformin plus calderasib	Drug: Metformin; Oral tablet; Drug: Rosuvastatin; Oral tablet; Drug: Calderasib; Oral tablet; Other Names: MK-1084

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Rosuvastatin	Blood samples will be collected at multiple time points to determine the 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	Blood samples will be collected at multiple time points to estimate AUC0-24	Day 1: Predose and at designated timepoints up to 24 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin	Blood samples will be collected at multiple time points to estimate Tmax	Day 1: Predose and at designated timepoints up to 120 hours post-dose
Day 1: Apparent Terminal Half-life (t1/2) of Rosuvastatin	Blood samples will be collected at multiple time points to estimate t1/2	Day 1: Predose and at designated timepoints up to 120 hours post-dose
Apparent Clearance (CL/F) of Rosuvastatin	Blood samples will be collected at multiple time points to estimate CL/F	Day 1: Predose and at designated timepoints up to 120 hours post-dose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Rosuvastatin	Blood samples will be collected at multiple time points to estimate Vz/F	Day 1: Predose and at designated timepoints up to 120 hours post-dose
AUC0-last of Metformin	Blood samples will be collected at multiple time points to estimate AUC0-last	Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-24hrs of Metformin	Blood samples will be collected at multiple time points to estimate AUC0-24	Day 1: Predose and at designated timepoints up to 24 hours post-dose
Cmax of Metformin	Blood samples will be collected at multiple time points to estimate Cmax	Day 1: Predose and at designated timepoints up to 72 hours post-dose
Tmax of Metformin	Blood samples will be collected at multiple time points to estimate Tmax	Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of Metformin	Blood samples will be collected at multiple time points to estimate t1/2	Day 1: Predose and at designated timepoints up to 72 hours post-dose
CL/F of Metformin	Blood samples will be collected at multiple time points to estimate CL/F	Day 1: Predose and at designated timepoints up to 72 hours post-dose
Vz/F of Metformin	Blood samples will be collected at multiple time points to estimate Vz/F	Day 1: Predose and at designated timepoints up to 72 hours post-dose
Amount of Metformin Excreted Unchanged in Urine (Ae)	Urine samples will be collected at multiple time points to estimate Ae	Day 1: Predose and at designated timepoints up to 48 hours post-dose
Fraction of Metformin Excreted Unchanged in Urine (Fe)	Urine samples will be collected at multiple time points to estimate Fe	Day 1: Predose and at designated timepoints up to 48 hours post-dose
Renal Clearance of Metformin (CLr)	Urine samples will be collected at multiple time points to estimate CLr	Day 1: Predose and at designated timepoints up to 48 hours post-dose
Number of Participants Who Experience an Adverse Avent (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE is reported.	Up to approximately 28 days after first dose
Number of Participants Who Discontinue Study Intervention Due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study treatment due to an AE is reported.	Up to approximately 14 days after first dose
AUC0-inf of Calderasib	Blood samples will be collected at multiple time points to estimate AUC0-inf	Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-last of Calderasib	Blood samples will be collected at multiple time points to estimate AUC0-last	Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-24hrs of Calderasib	Blood samples will be collected at multiple time points to estimate AUC0-24	Day 1: Predose and at designated timepoints up to 24 hours post-dose
Cmax of Calderasib	Blood samples will be collected at multiple time points to estimate Cmax	Day 1: Predose and at designated timepoints up to 72 hours post-dose
Plasma Concentration at 24 Hours (C24) of Calderasib	Blood samples will be collected to estimate C24	24 hours post-dose
Tmax of Calderasib	Blood samples will be collected at multiple time points to estimate Tmax	Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of Calderasib	Blood samples will be collected at multiple time points to estimate t1/2	Day 1: Predose and at designated timepoints up to 72 hours post-dose
CL/F of Calderasib	Blood samples will be collected at multiple time points to estimate CL/F	Day 1: Predose and at designated timepoints up to 72 hours post-dose
Vz/F of Calderasib	Blood samples will be collected at multiple time points to estimate Vz/F	Day 1: Predose and at designated timepoints up to 72 hours post-dose

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2025
• Primary Completion (Actual): December 14, 2025
• Study Completion (Actual): December 29, 2025

Study Registration Dates

• First Submitted: October 27, 2025
• First Submitted That Met QC Criteria: October 27, 2025
• First Posted (Actual): October 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Amides; Pyrimidines; Hydrocarbons, Halogenated; Biguanides; Guanidines; Amidines; Sulfonamides; Sulfones; Fluorobenzenes; Hydrocarbons, Fluorinated; Rosuvastatin Calcium; Metformin
• Other Study ID Numbers: 1084-016; MK-1084-016 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No