MK-8527 for Healthy Subjects

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Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Merck Sharp & Dohme LLC
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 aims to study how a new medicine, MK-8527, behaves in the bodies of healthy adults. It examines how MK-8527 works when taken with food and its interactions with other medicines like probenecid and itraconazole. Researchers seek to determine if MK-8527 is safe and well-tolerated, meaning participants can continue taking it without health problems. Individuals in good health with a body mass index (BMI) between 18 and 32 might be suitable for this study. As a Phase 1 trial, this research focuses on understanding how MK-8527 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that MK-8527 is likely to be safe for humans?

Research has shown that MK-8527 is generally well tolerated in adults. One study found that both single and multiple weekly doses of MK-8527 were well tolerated by adults without HIV, indicating likely safety. Other studies have reported no major severe side effects from MK-8527, which is being tested as a way to prevent HIV-1 infection. This evidence suggests that MK-8527 has been safe in the groups studied so far. However, since this study is in its early stages, the main goal is to understand how the drug works in the body, so more information about its safety will be collected.12345

Why are researchers excited about this trial's treatments?

MK-8527 is unique because it explores different combinations and interactions that could enhance its effectiveness. While current treatments for various conditions might rely on standard dosing or administration, MK-8527 is being tested both with and without food, as well as in combination with other drugs like probenecid and itraconazole. This approach could reveal new ways to optimize the drug’s performance, potentially leading to more flexible and effective treatment regimens. Researchers are excited about these possibilities because they could lead to better outcomes and improved quality of life for patients.

What evidence suggests that MK-8527 could be effective?

Studies have shown that MK-8527 is generally safe for adults without HIV. It quickly enters the bloodstream, allowing it to start working fast. This trial will administer MK-8527 in different contexts to study its interactions. Part 1 will assess MK-8527 with and without food. Part 2 will evaluate MK-8527 alone and with probenecid. Part 3 will examine MK-8527 alone and with itraconazole. Research indicates that MK-8527 can fight viruses like HIV. So far, MK-8527 has been safe and absorbed well in healthy adults, suggesting potential effectiveness in future treatments.678910

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for healthy adults with a BMI between 18 and 32. Participants should not have any significant health problems.

Inclusion Criteria

I am in good overall health.
My BMI is between 18 and 32.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Part 1

Participants receive a single dose of MK-8527 with and without food

2 weeks
Multiple visits for blood sampling

Treatment Part 2

Participants receive a single dose of MK-8527 alone and in combination with probenecid

2 weeks
Multiple visits for blood and urine sampling

Treatment Part 3

Participants receive a single dose of MK-8527 alone and in combination with itraconazole

2 weeks
Multiple visits for blood and urine sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 43 days

What Are the Treatments Tested in This Trial?

Interventions

  • MK-8527

Trial Overview

The study tests how the new medicine MK-8527 acts in the body, both alone and when taken with food or other medicines like Probenecid or Itraconazole. The focus is on safety and tolerance in healthy people.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Part 3: MK-8527 + ItraconazoleExperimental Treatment2 Interventions
Group II: Part 2: MK-8527 + ProbenecidExperimental Treatment2 Interventions
Group III: Part 1: MK-8527Experimental Treatment1 Intervention

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

Safety and Pharmacokinetics of MK-8527, a Novel nRTTI ...

Safety and Pharmacokinetics of MK-8527, a Novel nRTTI, in Adults. Retroviruses and Opportunistic Infections

Safety and Pharmacokinetics of MK‐8527 in Adults Without HIV

Single and multiple QW doses of MK‐8527 were generally well tolerated in adults without HIV. MK‐8527 had rapid absorption in plasma and uptake ...

A Study of MK-8527 in Human Immunodeficiency Type 1 ...

This study will evaluate the anti-retroviral activity of MK-8527 in HIV-1 infected, 168 hours postdose.

Antiretroviral Activity, Pharmacokinetics, and Safety of MK ...

Two Phase 1 single-dose monotherapy studies were conducted to evaluate antiretroviral activity, pharmacokinetics (PK), and safety of MK-8527 in adults with HIV ...

Alimatravir (MK-8527)

pharmacokinetics of MK-8527 oral once-monthly: a phase 2 study in adults at low risk of HIV-1 exposure–

Lenacapavir: A blueprint for innovation, regulation, and ...

Just six months after Gilead submitted LEN for review as an HIV prevention tool, the FDA approved the drug in June 2025 under a priority review ...

A Clinical Trial of MK-8527 and Rifampin in Adult Participants ...

Researchers are studying MK-8527, a new medicine for preventing HIV-1 (human immunodeficiency virus type 1) infection and want to learn if MK-8527 can be given ...

Merck to Present New Data on Daily, Weekly, and Monthly ...

MK-8527 as PrEP to reduce the risk of sexually acquired HIV-1 infection among women and adolescent girls in sub-Saharan Africa.

Immunodeficiency clinical trials at University of California Health

MK-8527 to Prevent Human Immunodeficiency Virus Type 1. The purpose of this study is to evaluate the safety and tolerability of DOR/ ...

MK-8527 de novo resistance selection in HIV-1 subtypes A, ...

In the Phase 2a clinical trial, 23 adults with untreated HIV-1 received either VH-499 or a placebo for 11 days before starting standard HIV ...