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: 2026-02-05
Study Results
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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RECRUITING
PHASE1
62 participants
INTERVENTIONAL
2026-01-22
2026-04-09
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Moxifloxacin 400 mg + Placebo (Arm 1)
Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR ulonivirine dose matched placebo + moxifloxacin 400 mg.
Moxifloxacin
Oral tablet
Ulonivirine Placebo
Oral tablet
Moxifloxacin Placebo
Oral tablet
Ulonivirine Dose 1 + Placebo (Arm 2)
Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR moxifloxacin dose matched placebo + ulonivirine Dose 1.
Ulonivirine
Oral tablet
Ulonivirine Placebo
Oral tablet
Moxifloxacin Placebo
Oral tablet
Interventions
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Ulonivirine
Oral tablet
Moxifloxacin
Oral tablet
Ulonivirine Placebo
Oral tablet
Moxifloxacin Placebo
Oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has body Mass Index (BMI) between 18 and 32 kg/m2, inclusive
Exclusion Criteria
* Has history of cancer (malignancy)
* Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
18 Years
60 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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ICON Early Phase Services (0001)
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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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
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