Suspended

Study of MK-8527's Impact on QTc Interval in Healthy Adults

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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.
What is being tested

MK-8527

+ Moxifloxacin
+ Placebo
Drug
Who is being recruted

Healthy

From 18 to 60 Years
+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 2025

See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Last updated: October 9, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 12, 2025Actual date on which the first participant was enrolled.

Researchers are exploring new ways to prevent HIV-1, the most common type of HIV, which harms the immune system. This study focuses on MK-8527, a potential new medicine for HIV prevention. Unlike existing methods that require daily pills or frequent injections, MK-8527 is a tablet taken once a month, aiming to make it easier for people to stick to their prevention plan. The study is important as it could offer a simpler, more convenient option for HIV-1 prevention, potentially improving adherence and reducing new infections. The study involves healthy adult participants and aims to understand if a higher dose of MK-8527 affects heart rhythm, measured by something called the QT interval. Participants will take the medicine orally, and their heart rhythms will be closely monitored to see if there are any changes. This is a phase 1 trial, meaning it's an early stage of testing to ensure safety and gather information on how the drug affects the body.

Official TitleA Double-Blind, Placebo-Controlled and Active-controlled Trial to Evaluate the Effect of a Supratherapeutic Dose of MK-8527 on the QTc Interval in Healthy Adult Participants 
Principal SponsorMerck Sharp & Dohme LLC
Last updated: October 9, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
42 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Healthy
Criteria
3 inclusion criteria required to participate
he main inclusion criteria include but are not limited to the following
Is in good health before randomization
Has body mass index (BMI) between 18 and 32 kg/m\^2, inclusive
4 exclusion criteria prevent from participating
he main exclusion criteria include but are not limited to the following
Has history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
Has history of cancer (malignancy)
Has positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants receive a single dose of MK-8527 followed by a single dose of moxifloxacin and a single dose of placebo depending on randomization.
Group II
Experimental
Participants receive a single dose of moxifloxacin followed by a single dose of MK-8527 and a single dose of placebo depending on randomization.
Group III
Experimental
Participants receive a single dose of placebo followed by a single dose of MK-8527 and a single dose of moxifloxacin depending on randomization.
Study Objectives
Primary Objectives

Change from Baseline in QTc following MK-8527 administration will be reported.
Secondary Objectives

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported.

Change from Baseline in QTc following moxifloxacin administration will be reported.

Blood samples will be collected at multiple time points to estimate AUC0-24 of MK-8527

Blood samples will be collected at multiple time points to estimate AUC0-168 of MK-8527

Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527

Blood samples will be collected at multiple time points to estimate Cmax of MK-8527

Blood samples will be collected at multiple time points to estimate Tmax of MK-8527

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Hassman Research Institute Marlton Site ( Site 0001)Marlton, United StatesSee the location
SuspendedOne Study Center