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

NCT07305831 | Completed Phase 1 FDA Drug

• 2 other identifiers: 8507-012MK-8507-012
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

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

  Baseline and up to approximately 24 hours

• Plasma Concentration of Ulonivirine at QTc Intervals (Cqtc)

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

  At designated timepoints (up to approximately 24 hours)

Secondary Outcomes (6)

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

  Baseline to up to approximately 24 hours

• Plasma concentration of Moxifloxacin at QTc intervals (Cqtc)

  At designated timepoints (up to approximately 24 hours)

• Maximum Plasma Concentration (Cmax) of Moxifloxacin

  At designated timepoints (up to approximately 168 hours)

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

  At designated timepoints (up to 168 hours)

• Maximum Plasma Concentration (Cmax) of Ulonivirine

  At designated timepoints (up to 168 hours)

Study Arms (2)

Moxifloxacin 400 mg + Placebo (Arm 1)

EXPERIMENTAL

Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR ulonivirine dose matched placebo + moxifloxacin 400 mg.

Drug: Moxifloxacin; Drug: Ulonivirine Placebo; Drug: Moxifloxacin Placebo

Ulonivirine Dose 1 + Placebo (Arm 2)

EXPERIMENTAL

Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR moxifloxacin dose matched placebo + ulonivirine Dose 1.

Drug: Ulonivirine; Drug: Ulonivirine Placebo; Drug: Moxifloxacin Placebo

Interventions

Ulonivirine DRUG

Oral tablet

Also known as: MK-8507, ULO

Ulonivirine Dose 1 + Placebo (Arm 2)

Moxifloxacin DRUG

Oral tablet

Moxifloxacin 400 mg + Placebo (Arm 1)

Ulonivirine Placebo DRUG

Oral tablet

Moxifloxacin 400 mg + Placebo (Arm 1); Ulonivirine Dose 1 + Placebo (Arm 2)

Moxifloxacin Placebo DRUG

Oral tablet

Moxifloxacin 400 mg + Placebo (Arm 1); Ulonivirine Dose 1 + Placebo (Arm 2)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

ICON Early Phase Services (0001)

San Antonio, Texas, 78209, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

ulonivirine; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: January 22, 2026
• Primary Completion: April 9, 2026
• Study Completion: April 9, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)