NCT07063238

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

A Double-Blind, Placebo-Controlled and Active-controlled Trial to Evaluate the Effect of a Supratherapeutic Dose of MK-8527 on the QTc Interval in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	MK-8527	Oral administration
DRUG	Moxifloxacin	Oral administration
DRUG	Placebo	Oral administration

Timeline

• Start date: 2025-08-12
• Primary completion: 2025-12-06
• Completion: 2025-12-29
• First posted: 2025-07-14
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study