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

June 25, 2025 updated by: Merck Sharp & Dohme LLC

An Open-label, Phase 1 Study to Characterize the Effects of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) on the Pharmacokinetics of MK-8527 in Healthy Participants

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion ( Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A: MK-8527
Participants receive a single dose of MK-8527.
Drug: MK-8527
Oral Capsule
Experimental: Treatment B: MK-8527 + FTC/TDF
Participants receive FTC/TDF then MK-8527.
Drug: MK-8527
Oral Capsule
Drug: FTC/TDF
Oral Tablet
Other Names:
  • emtricitabine/tenofovir disoproxil fumarate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Pre-dose and at designated time points up to 840 hours post dose
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
Time Frame: Pre-dose and at designated time points up to 840 hours post dose
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
Time Frame: Pre-dose and at designated time points up to 672 hours post dose
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
Time Frame: Pre-dose and at designated time points up to 840 hours post dose
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
Time Frame: Pre-dose and at designated time points up to 840 hours post dose
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
Time Frame: Pre-dose and at designated time points up to 840 hours post dose
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-Inf of MK-8527 in plasma
Time Frame: Pre-dose and at designated time points up to 120 hours post dose
Blood samples will be collected to determine the 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
Time Frame: Pre-dose and at designated time points up to 120 hours post dose
Blood samples will be collected to determine the 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
Time Frame: Pre-dose and at designated time points up to 120 hours post dose
Blood samples will be collected to determine the Cmax of MK-8527 in plasma.
Pre-dose and at designated time points up to 120 hours post dose
Tmax of MK-8527 in plasma
Time Frame: Pre-dose and at designated time points up to 120 hours post dose
Blood samples will be collected to determine the 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
Time Frame: Pre-dose and at designated time points up to 120 hours post dose
Blood samples will be collected to determine the t1/2 of MK-8527 in plasma.
Pre-dose and at designated time points up to 120 hours post dose
Apparent Clearance (CL/F) of MK-8527 in plasma
Time Frame: Pre-dose and at designated time points up to 120 hours post dose
Blood samples will be collected to determine the CL/F MK-8527 in plasma
Pre-dose and at designated time points up to 120 hours post dose
Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma
Time Frame: Pre-dose and at designated time points up to 120 hours post dose
Blood samples will be collected to determine the Vz/F of MK-8527 in plasma
Pre-dose and at designated time points up to 120 hours post dose
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 111 days
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. The number of participants who experience an AE will be reported.
Up to approximately 111 days
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 43 days
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. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 43 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2025

Primary Completion (Actual)

June 5, 2025

Study Completion (Actual)

June 17, 2025

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8527-016
  • MK-8527-016 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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