MK-8527 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 body processes a new treatment, MK-8527, in healthy individuals. Researchers will track its absorption, breakdown, and elimination. Ideal participants are those in good overall health, without a history of cancer, and who test negative for certain viral infections like hepatitis or HIV. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.
Do I have to stop taking my current medications for 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.
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 people. In earlier studies, participants taking MK-8527 experienced no serious side effects. Drug levels in the blood increased predictably with higher doses, aiding in understanding the drug's mechanism in the body. These results suggest that MK-8527 is safe for healthy adults.12345
Why do researchers think this study treatment might be promising?
MK-8527 is unique because it introduces a novel compound into the treatment landscape by utilizing the active ingredient [14C]MK-8527. Unlike standard treatments that primarily rely on existing medications, this investigational drug offers a new approach by being administered as a single oral dose, potentially simplifying the treatment regimen. Researchers are excited about MK-8527 because it could provide insights into the pharmacokinetics of the drug in healthy subjects, paving the way for future applications in addressing yet-to-be-determined conditions.
What evidence suggests that MK-8527 is effective for healthy subjects?
Research has shown that MK-8527 is a new drug capable of blocking a key enzyme the HIV virus needs to multiply, helping to stop the virus from spreading in the body. Studies have found that combining drugs like MK-8527 with other treatments can help manage HIV as a long-term condition rather than a deadly disease. Although limited information exists on MK-8527's effectiveness in people, it is under study for its potential to prevent HIV. These findings suggest that MK-8527 could play an important role in future HIV treatments.14678
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This clinical trial is for healthy adults with a BMI between 18 to 32 kg/m2. Participants should be in good overall health without any significant medical conditions.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 [14C]MK-8527 on Day 1
Follow-up
Participants are monitored for absorption, metabolism, and excretion of [14C]MK-8527
Safety Monitoring
Participants are monitored for adverse events and safety outcomes
What Are the Treatments Tested in This Trial?
Interventions
- MK-8527
Trial Overview
[14C]MK-8527 is being tested to understand how it's absorbed, metabolized, and excreted by the body in healthy individuals. This study will track the movement of the drug through the body over time.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive a single oral dose of \[14C\]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 ...
A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...
Safety and Pharmacokinetics of MK‐8527 in Adults Without ...
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 ...
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 ...
Study of MK-8527's Impact on QTc Interval in Healthy Adults
Study AimThis study aims to evaluate how the drug MK-8527 affects the QTc interval in healthy adults, providing details about any changes from the baseline.
MK-8527 is a novel inhibitor of HIV-1 reverse transcriptase ...
The advent of combination antiretroviral (ARV) regimens has transformed the outcome of HIV infection from fatal illness to a manageable, chronic condition [1].
Safety and Pharmacokinetic Study of Oral MK-8527 QM in ...
This double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in ...
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.
Safety and Pharmacokinetics of MK‐8527 in Adults Without HIV
MK-8527 was generally well tolerated with no serious adverse events. Plasma exposure of MK-8527 increased approximately dose-proportionally, and ...
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