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

Phase 1

Active, not recruiting

• Conditions: Healthy
• Interventions: Drug: MK-8527; Drug: FTC/TDF

• Registration Number: NCT06816043
• Lead Sponsor: Merck Sharp & Dohme LLC

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-04
• Study First Posted: 2025-02-10
• Study Start: 2025-02-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-06-05
• Study Completion: 2025-06-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A: MK-8527	MK-8527	Participants receive a single dose of MK-8527.
Treatment B: MK-8527 + FTC/TDF	MK-8527	Participants receive FTC/TDF then MK-8527.
Treatment B: MK-8527 + FTC/TDF	FTC/TDF	Participants receive FTC/TDF then MK-8527.

Primary Outcome Measures

Name	Time	Method
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)	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.
Area Under the Concentration-Time Curve from Time 0 to Last quantifiable sample (AUC0-last) of MK-8527-TP in PBMC	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.
Drug Concentration at 672 Hours (C672) of MK-8527-TP in PBMC	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.
Maximum Plasma Concentration (Cmax) of MK-8527-TP in PBMC	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.
Time to Maximum Plasma Concentration (Tmax) of MK-8527-TP in PBMC	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.
Apparent Terminal Half-life (t1/2) of MK-8527-TP in PBMC	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 Outcome Measures

Name	Time	Method
Apparent Clearance (CL/F) of MK-8527 in plasma	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
Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma	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
AUC0-Inf of MK-8527 in plasma	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.
AUC0-last of MK-8527 in plasma	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.
Cmax of of MK-8527 in plasma	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.
Tmax of MK-8527 in plasma	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.
t1/2 of MK-8527 in plasma	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.
Number of Participants Who Experience an Adverse Event (AE)	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.
Number of Participants Who Discontinue Study Treatment Due to an AE	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.

Trial Locations

Locations (1)

Celerion ( Site 0001); 🇺🇸 Lincoln, Nebraska, United States