Healthy
Conditions
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).
Interventions
DRUGMK-8527
Oral Capsule
DRUGFTC/TDF
Oral Tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
Countries
United States
Outcome results
None listed