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

NCT07063238 | Completed Phase 1 FDA Drug

• 2 other identifiers: 8527-014MK-8527-014
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in QT interval corrected for heart rate (QTc) following MK-8527 administration

  Change from Baseline in QTc following MK-8527 administration will be reported.

  Baseline and up to approximately 24 hours

Secondary Outcomes (8)

• Number of participants who experience one or more adverse events (AEs)

  Up to approximately 7 weeks

• Number of participants who discontinue study intervention due to an AE

  Up to approximately 7 weeks

• Change from Baseline in QTc following moxifloxacin administration

  Baseline and up to approximately 24 hours

• Area Under the Plasma Concentration-Time curve From Time 0 to 24 hours (AUC0-24) of MK-8527

  At designated timepoints (up to 24 hours postdose)

• Area Under the Plasma Concentration-Time curve From Time 0 to 168 hours (AUC0-168) of MK-8527

  At designated timepoints (up to 168 hours postdose)

Study Arms (3)

MK-8527 PLUS Moxifloxacin and Placebo

EXPERIMENTAL

Participants receive a single dose of MK-8527 followed by a single dose of moxifloxacin and a single dose of placebo depending on randomization.

Drug: MK-8527; Drug: Moxifloxacin; Drug: Placebo

Moxifloxacin PLUS MK-8527 and Placebo

EXPERIMENTAL

Participants receive a single dose of moxifloxacin followed by a single dose of MK-8527 and a single dose of placebo depending on randomization.

Drug: MK-8527; Drug: Moxifloxacin; Drug: Placebo

Placebo PLUS MK-8527 and Moxifloxacin

EXPERIMENTAL

Participants receive a single dose of placebo followed by a single dose of MK-8527 and a single dose of moxifloxacin depending on randomization.

Drug: MK-8527; Drug: Moxifloxacin; Drug: Placebo

Interventions

MK-8527 DRUG

Oral administration

MK-8527 PLUS Moxifloxacin and Placebo; Moxifloxacin PLUS MK-8527 and Placebo; Placebo PLUS MK-8527 and Moxifloxacin

Moxifloxacin DRUG

Oral administration

MK-8527 PLUS Moxifloxacin and Placebo; Moxifloxacin PLUS MK-8527 and Placebo; Placebo PLUS MK-8527 and Moxifloxacin

Placebo DRUG

Oral administration

MK-8527 PLUS Moxifloxacin and Placebo; Moxifloxacin PLUS MK-8527 and Placebo; Placebo PLUS MK-8527 and Moxifloxacin

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/m\^2, inclusive

You may not qualify if:

• Has history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological 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)

Hassman Research Institute Marlton Site ( Site 0001)

Marlton, New Jersey, 08053, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: August 12, 2025
• Primary Completion: December 6, 2025
• Study Completion: December 29, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)