MK-8527 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the new treatment, MK-8527, travels through the body and appears in breast milk. The main focus is to determine how much of the drug can pass to a baby through breastfeeding. The trial seeks women who are at least six weeks postpartum, have given birth to a healthy single baby, and can pump breast milk several times a day. Participants must be willing to stop breastfeeding and using pumped milk for at least six weeks after taking the study drug. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
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 or your doctor.
Is there any evidence suggesting that MK-8527 is likely to be safe for humans?
Research has shown that MK-8527 is generally safe for humans. In earlier studies, researchers did not link any serious health problems to the treatment, indicating that participants experienced no major health issues due to the drug. The studies also found that as the dose increased, drug levels in the body rose predictably, a positive sign for its safety. Overall, MK-8527 has demonstrated a promising safety record so far.12345
Why do researchers think this study treatment might be promising?
MK-8527 is unique because it offers a new approach by targeting specific pathways that current treatments do not address. Unlike traditional therapies that might require multiple doses or extended periods to take effect, MK-8527 is designed as a single oral dose, which could simplify the treatment process and improve patient compliance. Researchers are particularly excited about its potential to provide rapid and efficient results, which could significantly enhance treatment experiences compared to current options.
What evidence suggests that MK-8527 might be an effective treatment?
Research shows that MK-8527 is a promising treatment because it can block HIV from multiplying by using a novel mechanism to stop the virus. Similar treatments have effectively prevented HIV from spreading in the body. Early results suggest that MK-8527 might help prevent HIV, but further research is needed to confirm this. While direct proof of its effectiveness is not yet available, its design offers scientists hope for its future use in treating HIV.23456
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 lactating women who are at least 6 weeks postpartum, have delivered a healthy baby, and can express breast milk twice daily for over 120 hours after joining. Participants must stop breastfeeding from the time they take MK-8527 until six weeks after to ensure safety.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of MK-8527 on Day 1
Pharmacokinetic Monitoring
Breast milk, plasma, and blood samples are collected to measure MK-8527 concentration at various time points
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MK-8527
Trial Overview
Researchers are studying how MK-8527 is processed in the body and how much enters breast milk. They'll check levels of this drug in the milk at different times to understand what babies might ingest.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants receive single oral dose of MK-8527 on Day 1
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
A Clinical Study of MK-8527 in Healthy Adult Participants ...
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Participants who received MK‐8527 with a meal showed a 41% decrease in C max with no effect on AUC0–168, and a 20%, 22%, and 58% increase in ...
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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 ...
MK-8527 is a novel inhibitor of HIV-1 reverse transcriptase ...
Nucleoside reverse transcriptase translocation inhibitors (NRTTIs) are potent antiretroviral agents that block HIV replication.
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.
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