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Completed

NCT Number: NCT07222098

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

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

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Key information

Conditions

Healthy

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion ( Site 0001)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rosuvastatin

Drug

Oral tablet

metformin

Drug

Oral tablet

Calderasib

Drug

Oral tablet

Other names: MK-1084

Primary outcomes

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

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

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

  2. Maximum Plasma Concentration (Cmax) of Rosuvastatin

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

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

  3. AUC0-inf of Metformin

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

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

Secondary outcomes

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

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

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

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

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

    Blood samples will be collected at multiple time points to estimate AUC0-24

  3. Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin

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

    Blood samples will be collected at multiple time points to estimate Tmax

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

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

    Blood samples will be collected at multiple time points to estimate t1/2

  5. Apparent Clearance (CL/F) of Rosuvastatin

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

    Blood samples will be collected at multiple time points to estimate CL/F

  6. Apparent Volume of Distribution During Terminal Phase (Vz/F) of Rosuvastatin

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

    Blood samples will be collected at multiple time points to estimate Vz/F

  7. AUC0-last of Metformin

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

    Blood samples will be collected at multiple time points to estimate AUC0-last

  8. AUC0-24hrs of Metformin

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

    Blood samples will be collected at multiple time points to estimate AUC0-24

  9. Cmax of Metformin

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

    Blood samples will be collected at multiple time points to estimate Cmax

  10. Tmax of Metformin

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

    Blood samples will be collected at multiple time points to estimate Tmax

  11. t1/2 of Metformin

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

    Blood samples will be collected at multiple time points to estimate t1/2

  12. CL/F of Metformin

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

    Blood samples will be collected at multiple time points to estimate CL/F

  13. Vz/F of Metformin

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

    Blood samples will be collected at multiple time points to estimate Vz/F

  14. AUC0-inf of Calderasib

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

    Blood samples will be collected at multiple time points to estimate AUC0-inf

  15. AUC0-last of Calderasib

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

    Blood samples will be collected at multiple time points to estimate AUC0-last

  16. AUC0-24hrs of Calderasib

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

    Blood samples will be collected at multiple time points to estimate AUC0-24

  17. Cmax of Calderasib

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

    Blood samples will be collected at multiple time points to estimate Cmax

  18. Plasma Concentration at 24 Hours (C24) of Calderasib

    Time frame: 24 hours post-dose

    Blood samples will be collected to estimate C24

  19. Tmax of Calderasib

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

    Blood samples will be collected at multiple time points to estimate Tmax

  20. t1/2 of Calderasib

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

    Blood samples will be collected at multiple time points to estimate t1/2

  21. CL/F of Calderasib

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

    Blood samples will be collected at multiple time points to estimate CL/F

  22. Vz/F of Calderasib

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

    Blood samples will be collected at multiple time points to estimate Vz/F

  23. Amount of Metformin Excreted Unchanged in Urine (Ae)

    Time frame: Day 1: Predose and at designated timepoints up to 48 hours post-dose

    Urine samples will be collected at multiple time points to estimate Ae

  24. Fraction of Metformin Excreted Unchanged in Urine (Fe)

    Time frame: Day 1: Predose and at designated timepoints up to 48 hours post-dose

    Urine samples will be collected at multiple time points to estimate Fe

  25. Renal Clearance of Metformin (CLr)

    Time frame: Day 1: Predose and at designated timepoints up to 48 hours post-dose

    Urine samples will be collected at multiple time points to estimate CLr

  26. Number of Participants Who Experience an Adverse Avent (AE)

    Time frame: Up to approximately 28 days after first dose

    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.

  27. Number of Participants Who Discontinue Study Intervention Due to an AE

    Time frame: Up to approximately 14 days after first dose

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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