Suspended

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

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Study Aim

This 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

From 18 to 60 Years
+5 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: December 18, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: August 12, 2025

Actual 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 
NCT07063238
Principal SponsorMerck Sharp & Dohme LLC
Last updated: December 18, 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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Is in good health before randomization
Has body mass index (BMI) between 18 and 32 kg/m\^2, inclusive
3 exclusion criteria prevent from participating
Has positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
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).

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

Secondary Objectives

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