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Completed

NCT Number: NCT07305831

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

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Services (0001)

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ulonivirine

Drug

Oral tablet

Other names: MK-8507, ULO

moxifloxacin

Drug

Oral tablet

Ulonivirine Placebo

Drug

Oral tablet

Moxifloxacin Placebo

Drug

Oral tablet

Primary outcomes

  1. Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Ulonivirine Administration

    Time frame: Baseline and up to approximately 24 hours

    Change from baseline in QTc following ulonivirine administration will be reported.

  2. Plasma Concentration of Ulonivirine at QTc Intervals (Cqtc)

    Time frame: At designated timepoints (up to approximately 24 hours)

    Blood samples will be collected to determine the Cqtc of ulonivirine.

Secondary outcomes

  1. Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Administration

    Time frame: Baseline to up to approximately 24 hours

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

  2. Plasma concentration of Moxifloxacin at QTc intervals (Cqtc)

    Time frame: At designated timepoints (up to approximately 24 hours)

    Blood samples will be collected to determine the Cqtc of moxifloxacin.

  3. Maximum Plasma Concentration (Cmax) of Moxifloxacin

    Time frame: At designated timepoints (up to approximately 168 hours)

    Blood samples will be collected to determine the Cmax of moxifloxacin.

  4. Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ulonivirine

    Time frame: At designated timepoints (up to 168 hours)

    Blood samples will be collected to determine the AUC0-24 of ulonivirine.

  5. Maximum Plasma Concentration (Cmax) of Ulonivirine

    Time frame: At designated timepoints (up to 168 hours)

    Blood samples will be collected to determine the Cmax of ulonivirine.

  6. Time to Maximum Plasma Concentration (Tmax) of Ulonivirine

    Time frame: At designated timepoints (up to 168 hours)

    Blood samples will be collected to determine the Tmax of ulonivirine.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of MK-8507 on the QTc Interval in Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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