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

NCT06816043 | Completed Phase 1 FDA Drug

• 2 other identifiers: 8527-016MK-8527-016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Area Under the Concentration-Time Curve from Time 0 to Infinity after single dosing (AUC0-Inf) of MK-8527-Triphosphate (TP) in peripheral blood mononuclear cell (PBMC)

  Blood samples will be collected to determine the AUC0-Inf of MK-8527-TP in PBMC.

  Pre-dose and at designated time points up to 840 hours post dose

• Area Under the Concentration-Time Curve from Time 0 to Last quantifiable sample (AUC0-last) of MK-8527-TP in PBMC

  Blood samples will be collected to determine the AUC0-last of MK-8527-TP in PBMC.

  Pre-dose and at designated time points up to 840 hours post dose

• Drug Concentration at 672 Hours (C672) of MK-8527-TP in PBMC

  Blood samples will be collected to determine the C672 of MK-8527-TP in PBMC.

  Pre-dose and at designated time points up to 672 hours post dose

• Maximum Plasma Concentration (Cmax) of MK-8527-TP in PBMC

  Blood samples will be collected to determine the Cmax of MK-8527-TP in PBMC.

  Pre-dose and at designated time points up to 840 hours post dose

• Time to Maximum Plasma Concentration (Tmax) of MK-8527-TP in PBMC

  Blood samples will be collected to determine the Tmax of MK-8527-TP in PBMC.

  Pre-dose and at designated time points up to 840 hours post dose

• Apparent Terminal Half-life (t1/2) of MK-8527-TP in PBMC

  Blood samples will be collected to determine the t1/2 of MK-8527-TP in PBMC.

  Pre-dose and at designated time points up to 840 hours post dose

Secondary Outcomes (9)

• AUC0-Inf of MK-8527 in plasma

  Pre-dose and at designated time points up to 120 hours post dose

• AUC0-last of MK-8527 in plasma

  Pre-dose and at designated time points up to 120 hours post dose

• Cmax of of MK-8527 in plasma

  Pre-dose and at designated time points up to 120 hours post dose

• Tmax of MK-8527 in plasma

  Pre-dose and at designated time points up to 120 hours post dose

• t1/2 of MK-8527 in plasma

  Pre-dose and at designated time points up to 120 hours post dose

Study Arms (2)

Treatment A: MK-8527

EXPERIMENTAL

Participants receive a single dose of MK-8527.

Drug: MK-8527

Treatment B: MK-8527 + FTC/TDF

EXPERIMENTAL

Participants receive FTC/TDF then MK-8527.

Drug: MK-8527; Drug: FTC/TDF

Interventions

MK-8527 DRUG

Oral Capsule

Treatment A: MK-8527; Treatment B: MK-8527 + FTC/TDF

FTC/TDF DRUG

Oral Tablet

Also known as: emtricitabine/tenofovir disoproxil fumarate

Treatment B: MK-8527 + FTC/TDF

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion ( Site 0001)

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: February 21, 2025
• Primary Completion: June 5, 2025
• Study Completion: June 17, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)