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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8591-058 | Other Identifier | MSD |
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The goal of this study is to learn what happens to the medication islatravir (ISL), in a healthy person's body over time--called a pharmacokinetic (PK) study. Researchers want to compare the amount of islatravir in the blood when it is taken alone as a single dose and when it is taken with multiple doses of another medication called lamivudine (3TC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISL and 3TC | Experimental | During period 1, participants receive a single dose of islatravir (ISL). During Period 2, participants receive multiple once-daily doses of lamivudine (3TC) for 27 days, and a single dose of ISL co-administered with 3TC on day 6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Islatravir (ISL) | Drug | Oral administration of a single dose in period 1 and period 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral blood mononuclear cell (PBMC) Concentration at 168 hours (C168) of islatravir-triphosphate (ISL-TP ) | Blood samples will be collected to determine the C168 of ISL-TP | Predose and at designated timepoints up to 168 hours post dose |
| PBMC Concentration at 24 Hours (C24) of ISL-TP | Blood samples will be collected to determine the C24 of ISL-TP | Predose and at designated timepoints up to 24 hours post dose |
| PBMC Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of ISL-TP | Blood samples will be collected to determine the AUC0-inf of ISL-TP | Predose and at designated timepoints up to 840 hours post dose |
| PBMC Area Under the Concentration-time Curve to Time of Last Measurable Concentration (AUClast) of ISL-TP | Blood samples will be collected to determine the AUClast of ISL-TP | Predose and at designated time points up to 840 hours post dose |
| PBMC Maximum Concentration (Cmax) of ISL-TP | Blood samples will be collected to determine the Cmax of ISL-TP | Predose and at designated time points up to 840 hours post dose |
| PBMC Time to Maximum Concentration (Tmax) of ISL-TP | Blood samples will be collected to determine the Tmax of ISL-TP | Predose and at designated time points up to 840 hours post dose |
| PBMC Apparent Terminal Half-life (t1/2) of ISL-TP |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma C168 of ISL | Blood samples will be collected to determine the C168 of ISL | Predose and at designated timepoints up to 168 hours post dose |
| Plasma Concentration at 24 Hours (C24) of ISL | Blood samples will be collected to determine the C24 of ISL |
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Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key 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 |
|---|---|
| C558823 | islatravir |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Lamivudine (3TC) | Drug | Oral administration of multiple daily doses for 27 days |
|
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Blood samples will be collected to determine the t1/2 of ISL-TP |
| Predose and at designated timepoints up to 840 hours post dose |
| Predose and at designated timepoints up to 24 hours post dose |
| Plasma AUC0-inf of ISL | Blood samples will be collected to determine the AUC0-inf of ISL | Predose and at designated timepoints up to 168 hours post dose |
| Plasma AUClast of ISL | Blood samples will be collected to determine the AUClast of ISL | Predose and at designated timepoints up to 168 hours post dose |
| Plasma Cmax of ISL | Blood samples will be collected to determine the Cmax of ISL | Predose and at designated timepoints up to 168 hours post dose |
| Plasma Tmax of ISL | Blood samples will be collected to determine the Tmax of ISL-TP | Predose and at designated timepoints up to 168 hours post dose |
| Plasma t1/2 of ISL | Blood samples will be collected to determine the t1/2 of ISL | Predose and at designated timepoints up to 168 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 16 weeks |
| 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 10 weeks |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |