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MK-8527 for Methadone Interaction Study

TF
Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Merck Sharp & Dohme LLC
Must be taking: Methadone
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 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.12345

Why 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?

MD

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

Has a body-mass index (BMI) between 18 and 35 kg/m^2

Exclusion Criteria

Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
Has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e., systemic allergic reaction) to prescription or nonprescription drugs or food
Has a positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of MK-8527 with methadone to study pharmacokinetics

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

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

Group I: Methadone + MK-8527Experimental 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

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,