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MK-2828 for Healthy Subjects

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Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Merck Sharp & Dohme LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, MK-2828 (experimental treatment), to observe its effects on two other drugs, rosuvastatin and furosemide, in the body. The focus is on heart failure with preserved ejection fraction (HFpEF), a condition where the heart is stiff and doesn't relax well. Participants will take MK-2828 with either rosuvastatin or furosemide to monitor interactions. Individuals who are generally healthy and have a body mass index (BMI) between 18 and 32 might be suitable for this trial. As a Phase 1 trial, the research aims to understand how MK-2828 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves testing how MK-2828 affects rosuvastatin or furosemide, you might need to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rosuvastatin, a drug commonly used to lower cholesterol, is generally well tolerated. Studies indicate it has a safety profile similar to other cholesterol-lowering drugs, with mostly mild side effects. The FDA has already approved it, confirming its safety for current uses.

MK-2828 is a new medicine under testing for treating heart failure with preserved ejection fraction (HFpEF). The current trial is in its early stages, primarily aiming to understand how the body processes MK-2828. This phase typically involves a small group of healthy volunteers to identify any safety concerns. Limited data on MK-2828's safety exist so far, but early studies suggest the need for careful monitoring of side effects.

Furosemide, another drug in the trial, is a diuretic that helps remove extra fluid from the body. It is well-known and widely used, with its safety well-documented.

Overall, researchers are carefully studying the combination of these drugs for safety, especially since MK-2828 is new. Participants receive close monitoring for any side effects during the trial.12345

Why do researchers think this study treatment might be promising for heart failure?

MK-2828 is unique because it combines with existing drugs like rosuvastatin and furosemide to potentially enhance their effects. Unlike the standard treatments for conditions like high cholesterol or fluid retention, which involve taking multiple medications separately, MK-2828 could streamline therapy by working synergistically with these drugs. Researchers are excited about these combinations because MK-2828 may introduce a new mechanism of action, possibly providing more efficient and effective treatment outcomes. This could mean improved patient compliance and better overall health results.

What evidence suggests that this trial's treatments could be effective for HFpEF?

Research is investigating MK-2828 as a potential treatment for heart failure with preserved ejection fraction (HFpEF). While direct evidence of its effectiveness remains limited, scientists are examining its interactions with other medications. In this trial, participants will receive either a combination of MK-2828 and rosuvastatin or MK-2828 and furosemide. Rosuvastatin lowers "bad" LDL cholesterol, and furosemide helps the body eliminate excess fluid by increasing urination. These actions are important for managing heart conditions. Early studies are exploring whether MK-2828 can enhance these effects, prompting researchers' interest in its potential.13678

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for healthy adults with a BMI between 18 and 32 who do not have any major health problems. People with certain medical conditions or on specific medications may not be able to join.

Inclusion Criteria

* Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2
* Is in good health

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rosuvastatin or furosemide along with MK-2828 to evaluate pharmacokinetic interactions

2 weeks
Multiple visits for blood sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MK-2828

Trial Overview

The study tests if the new drug MK-2828 changes how the body processes two common medicines, rosuvastatin (for cholesterol) and furosemide (a water pill), in healthy volunteers.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Rosuvastatin + MK-2828Experimental Treatment2 Interventions
Group II: Furosemide + MK-2828Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

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