Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)

Merck Sharp & Dohme LLC352 enrolled

Overview

This double-blind, placebo-controlled study was designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

352

Conditions

HIV HIV Pre-exposure Prophylaxis

Interventions

MK-8527DRUG

MK-8527 capsule

Placebo to MK-8527DRUG

Placebo capsule matched to MK-8527

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization * Has low-risk of HIV infection * Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses an acceptable contraception or is abstinent from penile-vaginal intercourse Exclusion Criteria: * Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator * Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid \[RNA\]) * Prior use of MK-8527 or islatravir (MK-8591)

Locations (18)

Velocity Clinical Research, North Hollywood ( Site 0054)

North Hollywood, California, United States

Outcomes

Primary Outcomes

Number of Participants With ≥1 Adverse Event (AE)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame: Up to ~28 weeks

Number of Participants Discontinuing Study Therapy Due to Adverse Event (AE)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame: Up to ~20 weeks

Secondary Outcomes

Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527

The plasma AUC0-last of MK-8527 is reported.

Time frame: Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose

Maximum Plasma Concentration (Cmax) of MK-8527

The plasma Cmax of MK-8527 is reported.

Time frame: Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose

Data from ClinicalTrials.gov

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