Clinical trial NCT06816043: A Study of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) and MK-8527 in Healthy Participants
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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)

Primary outcomes:
measure: 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)
timeFrame: Pre-dose and at designated time points up to 840 hours post dose
measure: Area Under the Concentration-Time Curve from Time 0 to Last quantifiable sample (AUC0-last) of MK-8527-TP in PBMC
timeFrame: Pre-dose and at designated time points up to 840 hours post dose
measure: Drug Concentration at 672 Hours (C672) of MK-8527-TP in PBMC
timeFrame: Pre-dose and at designated time points up to 672 hours post dose
measure: Maximum Plasma Concentration (Cmax) of MK-8527-TP in PBMC
timeFrame: Pre-dose and at designated time points up to 840 hours post dose
measure: Time to Maximum Plasma Concentration (Tmax) of MK-8527-TP in PBMC
timeFrame: Pre-dose and at designated time points up to 840 hours post dose
measure: Apparent Terminal Half-life (t1/2) of MK-8527-TP in PBMC
timeFrame: Pre-dose and at designated time points up to 840 hours post dose
Secondary outcomes:
measure: AUC0-Inf of MK-8527 in plasma
timeFrame: Pre-dose and at designated time points up to 120 hours post dose
measure: AUC0-last of MK-8527 in plasma
timeFrame: Pre-dose and at designated time points up to 120 hours post dose
measure: Cmax of of MK-8527 in plasma
timeFrame: Pre-dose and at designated time points up to 120 hours post dose
measure: Tmax of MK-8527 in plasma
timeFrame: Pre-dose and at designated time points up to 120 hours post dose
measure: t1/2 of MK-8527 in plasma
timeFrame: Pre-dose and at designated time points up to 120 hours post dose
measure: Apparent Clearance (CL/F) of MK-8527 in plasma
timeFrame: Pre-dose and at designated time points up to 120 hours post dose
measure: Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma
timeFrame: Pre-dose and at designated time points up to 120 hours post dose
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 111 days
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 43 days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion ( Site 0001)
state: Nebraska
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: