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MK-1084 Effects on Rosuvastatin and Metformin in Healthy Individuals

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What is being tested

Rosuvastatin

+ Metformin
+ MK-1084
Drug
Who is being recruted

Healthy

From 19 to 60 Years
+3 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Phase 1
Interventional
Study Start: November 2025

See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Last updated: October 29, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 18, 2025Actual date on which the first participant was enrolled.

This study aims to understand how a new drug, MK-1084, affects the levels of two commonly used medications, rosuvastatin and metformin, in the bodies of healthy individuals. Rosuvastatin is typically used to lower cholesterol, and metformin is often prescribed for managing blood sugar levels in people with type 2 diabetes. By observing how MK-1084 influences these drugs, researchers hope to determine if it changes the way these medications are processed in the body, which could be important for ensuring safe and effective use of these drugs in combination in future treatments. Participants in the study will receive single doses of rosuvastatin and metformin, both with and without MK-1084, in different periods of the study. This approach helps researchers compare the amount of rosuvastatin and metformin in the body over time under both conditions. The study aims to measure how MK-1084 influences the absorption, breakdown, and elimination of these medications. There are no specific risks or benefits mentioned for participants, but close monitoring ensures participant safety while gathering valuable data on drug interactions.

Official TitleAn 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 
Principal SponsorMerck Sharp & Dohme LLC
Last updated: October 29, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
16 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 19 to 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Healthy
Criteria
1 inclusion criteria required to participate
Has body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2
2 exclusion criteria prevent from participating
Has history of cancer (malignancy)
Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants will receive rosuvastatin plus metformin
Group II
Experimental
Participants will receive rosuvastatin plus metformin plus MK-1084
Study Objectives
Primary Objectives

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Blood samples will be collected to estimate C24

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

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

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

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

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

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

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

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.

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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