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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8527-016 | Other Identifier | MSD |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: MK-8527 | Experimental | Participants receive a single dose of MK-8527. |
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| Treatment B: MK-8527 + FTC/TDF | Experimental | Participants receive FTC/TDF then MK-8527. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8527 | Drug | Oral Capsule |
| |
| 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) | 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 | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-Inf of MK-8527 in plasma | 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 |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion ( Site 0001) | Lincoln | Nebraska | 68502 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| FTC/TDF |
| Drug |
Oral Tablet |
|
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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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 |
| D000068679 |
| Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |