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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-21

Study Completion Date

2025-06-17

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A: MK-8527

Participants receive a single dose of MK-8527.

Group Type EXPERIMENTAL

MK-8527

Intervention Type DRUG

Oral Capsule

Treatment B: MK-8527 + FTC/TDF

Participants receive FTC/TDF then MK-8527.

Group Type EXPERIMENTAL

MK-8527

Intervention Type DRUG

Oral Capsule

FTC/TDF

Intervention Type DRUG

Oral Tablet

Interventions

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MK-8527

Oral Capsule

Intervention Type DRUG

FTC/TDF

Oral Tablet

Intervention Type DRUG

Other Intervention Names

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emtricitabine/tenofovir disoproxil fumarate

Eligibility Criteria

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Inclusion Criteria

* 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

* 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)

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes