MK-1084 + Rosuvastatin + Metformin for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how the new drug, MK-1084, interacts with rosuvastatin and metformin in healthy individuals. Researchers seek to measure the levels of rosuvastatin and metformin in the body over time, both with and without MK-1084. Participants will join one of two groups: one receiving only rosuvastatin and metformin, and the other receiving those plus MK-1084. Ideal participants are healthy individuals with a BMI between 18 and 32, without a history of cancer or certain viral infections like HIV or hepatitis. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for more details.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that MK-1084, whether used alone or with other treatments, generally has a manageable safety profile, meaning most people have not experienced serious side effects. Early data suggest that MK-1084 is usually well-tolerated, whether taken by itself or with other drugs.
When combined with rosuvastatin and metformin, no specific safety risks have been identified in the available information. Rosuvastatin and metformin are common medications and are generally safe for most people when used as directed. This study aims to understand how MK-1084 affects the processing of these drugs in the body, rather than to test for safety issues.
As a Phase 1 trial, this study is one of the first steps in testing this combination in people. Early phase trials focus heavily on safety, so researchers will closely monitor participants' reactions to the treatment.
Overall, the treatment appears safe based on current information, but this study will help confirm that.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because MK-1084 is being tested in combination with rosuvastatin and metformin, which are well-known for managing cholesterol and blood sugar levels, respectively. Unlike the standard treatments that primarily target cholesterol or glucose separately, this combination aims to enhance the overall metabolic profile by potentially improving both lipid and glucose metabolism simultaneously. The inclusion of MK-1084 is particularly intriguing because it might offer a novel mechanism of action that could amplify the effects of rosuvastatin and metformin, offering a more comprehensive approach to metabolic health. This could lead to more effective management of conditions like metabolic syndrome, with the potential for improved outcomes over existing treatments.
What evidence suggests that this trial's treatments could be effective?
This trial will compare the effects of two different treatment combinations. One group of participants will receive rosuvastatin plus metformin, while another group will receive rosuvastatin, metformin, and MK-1084. Researchers are studying how MK-1084 affects the levels of rosuvastatin and metformin in the body. These studies explore how MK-1084 might alter the absorption, processing, and elimination of these drugs. Although specific data on MK-1084's effectiveness for any condition is not yet available, the main goal is to understand its interaction with rosuvastatin and metformin. This could enhance the future use of these medications.23678
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for healthy individuals with a BMI between 18.0 and 32.0 kg/m^2 who are interested in participating in research on the drug MK-1084, combined with rosuvastatin and metformin.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rosuvastatin and metformin, with and without MK-1084, to evaluate pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MK-1084
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
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
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