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A Clinical Trial to Evaluate the Effect of Ulonivirine (MK-8507) on Heart Rhythm in Healthy Adults (MK-8507-012)

NCT ID: NCT07305831

Last Updated: 2025-12-26

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

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-13

Study Completion Date

2026-04-09

Brief Summary

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Researchers are looking for new treatments for HIV-1 (human immunodeficiency virus type 1) that are safe, well-tolerated, and can be taken less often. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system.

Ulonivirine (MK-8507) is a study medicine designed to treat HIV-1

The goal of this study is to learn if ulonivirine does not increase the QT interval (a measure of heart rhythm on an electrocardiogram) above a certain amount. Researchers also want to learn what happens to the amount of ulonivirine in a healthy person's body over time.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1

Participants will receive ulonivirine dose matched placebo PLUS moxifloxacin dose matched placebo or ulonivirine dose matched placebo PLUS moxifloxacin Dose 1.

Group Type EXPERIMENTAL

Moxifloxacin

Intervention Type DRUG

Oral tablet

Ulonivirine Placebo

Intervention Type DRUG

Oral tablet

Moxifloxacin Placebo

Intervention Type DRUG

Oral tablet

Arm 2

Participants will receive ulonivirine dose matched placebo PLUS moxifloxacin dose matched placebo or moxifloxacin dose matched placebo PLUS ulonivirine Dose 1.

Group Type EXPERIMENTAL

Ulonivirine

Intervention Type DRUG

Oral tablet

Ulonivirine Placebo

Intervention Type DRUG

Oral tablet

Moxifloxacin Placebo

Intervention Type DRUG

Oral tablet

Interventions

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Ulonivirine

Oral tablet

Intervention Type DRUG

Moxifloxacin

Oral tablet

Intervention Type DRUG

Ulonivirine Placebo

Oral tablet

Intervention Type DRUG

Moxifloxacin Placebo

Oral tablet

Intervention Type DRUG

Other Intervention Names

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MK-8507 ULO

Eligibility Criteria

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Inclusion Criteria

* Is in good health before randomization
* Has body Mass Index (BMI) between 18 and 32 kg/m2, inclusive

Exclusion Criteria

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) 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

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-8507-012

Identifier Type: OTHER

Identifier Source: secondary_id

8507-012

Identifier Type: -

Identifier Source: org_study_id