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Status
Planned
Phase
Open Label
I
Objective
This is a single-dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8527 in antiretroviral therapy (ART)-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. The primary hypothesis is that, at a dose that is safe and generally well tolerated, MK-8527 will have antiretroviral activity as measured by a reduction from baseline in plasma HIV-1 ribonucleic acid (RNA) of ≥1.0 log10 copies/mL.
Last updated September 20, 2022
Prevention Option(s)
Treatment
Study Design
Open label
Arms and Assigned Interventions
Description
Experimental: Panel A: MK-8527 1.0 mg
Participants receive a single oral dose of MK-8527 1.0 mg.
Mode of Delivery
Tablet
Products
MK-8527
ARMs
Experimental
Description
Experimental: Panel B: MK-8527 ≤10.0 mg
Participants receive a single oral dose of MK-8527 ≤10.0 mg.
Mode of Delivery
Tablet
Products
MK-8527
ARMs
Experimental
Description
Experimental: Panel C: MK-8527 ≤10.0 mg
Participants receive a single oral dose of MK-8527 ≤10.0 mg.
Mode of Delivery
Tablet
Products
MK-8527
ARMs
Experimental
Official Code
Trial Sponsors
Merck Sharp & Dohme LLC
September 2022
September 2022
Enrollment
20
18
Years
60
Years
Population
Men
Women