MK-8527 for Methadone Interaction Study
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a new medicine, MK-8527, interacts with methadone, commonly used for pain relief or addiction treatment. Researchers aim to determine how MK-8527 affects methadone levels in the body over time. The trial specifically targets healthy individuals without a history of significant medical issues, such as heart or liver diseases. Participants should also not have severe allergies or positive tests for hepatitis or HIV. This study aims to understand the safety and interaction of these medicines when taken together. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking 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 methadone, it's likely that you will need to continue taking it as part of the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that MK-8527 is generally safe for people. In earlier studies, participants tolerated MK-8527 well without serious side effects. One study found that taking MK-8527 once a month did not cause major health problems compared to a placebo. Additionally, MK-8527 has been tested in other trials for preventing HIV, further supporting its safety.
Although this study is in the early stages, these results suggest that MK-8527 is likely safe when used with methadone. However, as with any treatment, individual experiences may differ.12345Why do researchers think this study treatment might be promising?
Researchers are excited about MK-8527 because it offers a unique approach to managing methadone interactions. Unlike traditional treatments that focus solely on methadone's effects, MK-8527 targets specific pathways to potentially enhance methadone's safety and effectiveness. This novel mechanism could help optimize methadone therapy, making it more efficient and safer for patients who require this medication for pain management or opioid addiction treatment.
What evidence suggests that this trial's treatments could be effective?
Research has shown that MK-8527 is being explored as a potential drug to prevent HIV. It has demonstrated promising results in combating the virus in people with HIV. Early studies found that it is well absorbed when taken orally and remains active in the body for an extended period. In this trial, participants will receive both methadone and MK-8527 to understand how MK-8527 interacts with methadone, a drug used to treat opioid addiction. Although specific data on its interaction with methadone is not yet available, the prolonged activity of MK-8527 in the body suggests potential for its use.23467
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharpe & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for healthy adults with a body mass index (BMI) between 18 and 35. Participants should not have any major health issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of MK-8527 with methadone to study pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Methadone
- MK-8527
Trial Overview
The study tests how a single dose of the drug MK-8527 affects methadone levels in the body. Healthy volunteers will receive both drugs, and researchers will monitor how methadone is processed over time.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive methadone and MK-8527.
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
Citations
MK-8527
MK-8527 is an investigational antiretroviral (ARV) drug that is being studied as a potential PrEP product. Below are details on its distinct characteristics.
MK-8527 - Health Professional Drug Record | NIH
Results demonstrated that coadministration of MK-8527 with LNG/EE had no significant effect on the PK of LNG or EE.15,16
NCT07044297 | A Clinical Study of MK-8527 to Prevent ...
The goals of this study are to learn: If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure ...
Merck to Initiate Phase 3 Trials for Investigational Once ...
The EXPrESSIVE-11 (MK-8527-011, NCT 07044297) trial will evaluate the safety and efficacy of MK-8527 among people with greater likelihood of HIV ...
Safety and Pharmacokinetics of MK‐8527 in Adults Without HIV
These results support the conclusion that MK‐8527 can be administered regardless of food. Weekly oral doses of MK‐8527 resulted in minimal drug ...
Safety and Pharmacokinetic Study of Oral MK-8527 QM in ...
An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...
Clinical Study to Evaluate the Efficacy and Safety of MK ...
This research study is testing a PrEP drug, MK-8527, in people who could be exposed to HIV-1. The purpose of this trial is to test the safety of the trial drug,
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