A Study of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) and MK-8527 in Healthy Participants

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy

Treatments: Drug: MK-8527; Drug: FTC/TDF

Study type: Interventional

Funder types: Industry

Identifiers

NCT06816043

MK-8527-016 (Other Identifier)

8527-016

Details and patient eligibility

About

The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to learn if there is a difference in the healthy person's body when MK-8527 is taken as a single dose (Treatment A) or with the medication Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) (Treatment B).

Enrollment: 20 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

• Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
• Has body mass index (BMI) ≥18 and ≤32.0 kg/m^2

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

• History of low bone density, renal impairment, Fanconi syndrome, autoimmune disorders (such as Graves' disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis), liver disease
• History of cancer (malignancy)
• Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Treatment A: MK-8527

Experimental group

Description:

Participants receive a single dose of MK-8527.

Treatment:

Drug: MK-8527

Treatment B: MK-8527 + FTC/TDF

Experimental group

Description:

Participants receive FTC/TDF then MK-8527.

Treatment:

Drug: FTC/TDF

Drug: MK-8527