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Completed

NCT Number: NCT06816043

A Study of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) and 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).

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion ( Site 0001)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MK-8527

Drug

Oral Capsule

FTC/TDF

Drug

Oral Tablet

Other names: emtricitabine/tenofovir disoproxil fumarate

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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