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A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014)

NCT ID: NCT07063238

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-12

Study Completion Date

2025-12-23

Brief Summary

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Researchers are looking for new medicines to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. Medicines to prevent HIV-1 infection are called pre-exposure prophylaxis (PrEP). Some people may have trouble following a PrEP plan because it involves either taking medicine everyday by mouth or getting injections (shots) often.

MK-8527 is a study medicine designed to prevent HIV-1 infection. MK-8527 is different from standard (usual) PrEP because it is taken once a month, by mouth, as a tablet.

The goal of this study is to learn if taking a higher-than-normal dose of MK-8527 increases the QT interval (a measure of heart rhythm) by a certain amount.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MK-8527 PLUS Moxifloxacin and Placebo

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 Type EXPERIMENTAL

MK-8527

Intervention Type DRUG

Oral administration

Moxifloxacin

Intervention Type DRUG

Oral administration

Placebo

Intervention Type DRUG

Oral administration

Moxifloxacin PLUS MK-8527 and Placebo

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 Type EXPERIMENTAL

MK-8527

Intervention Type DRUG

Oral administration

Moxifloxacin

Intervention Type DRUG

Oral administration

Placebo

Intervention Type DRUG

Oral administration

Placebo PLUS MK-8527 and Moxifloxacin

Participants receive a single dose of placebo followed by a single dose of MK-8527 and a single dose of moxifloxacin depending on randomization.

Group Type EXPERIMENTAL

MK-8527

Intervention Type DRUG

Oral administration

Moxifloxacin

Intervention Type DRUG

Oral administration

Placebo

Intervention Type DRUG

Oral administration

Interventions

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MK-8527

Oral administration

Intervention Type DRUG

Moxifloxacin

Oral administration

Intervention Type DRUG

Placebo

Oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Is in good health before randomization
* Has body mass index (BMI) between 18 and 32 kg/m\^2, inclusive

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Hassman Research Institute Marlton Site ( Site 0001)

Marlton, New Jersey, United States

Site Status

Countries

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United States

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-8527-014

Identifier Type: OTHER

Identifier Source: secondary_id

8527-014

Identifier Type: -

Identifier Source: org_study_id