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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8507-016 | Other Identifier | MSD |
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The main goals of this study are to learn what happens to Islatravir or MK-8507 in a person's body over time. Researchers will compare Islatravir given alone to Islatravir given with MK-8507. Researchers will also compare MK-8507 given alone to MK-8507 given with Islatravir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Islatravir+MK-8507 | Experimental | Period 1: Participants receive single dose of Islatravir on Day 1. Period 2: Participants receive single dose of MK-8507 on Days 1 and Days 8. Period 3: Participants receive single dose of Islatravir and single dose of MK-8507 on Day 1, 7 days after the Day 8 dose of MK-8507, during Period 2. Participants will receive additional MK-8507 single doses on Days 8, 15, 22, and 29. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8507 | Drug | Oral administration |
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| Islatravir |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite | Blood samples will be collected to determine the AUC0-Inf of Islatravir metabolite. | At designated timepoints (up to approximately 43 days) |
| Area Under the Concentration-Time Curve from Time 0 to 168 hours (AUC0-168hrs) of Islatravir Metabolite | Blood samples will be collected to determine the AUC0-168hrs of Islatravir metabolite. | At designated timepoints (up to approximately 168 hours) |
| Maximum Concentration (Cmax) of Islatravir Metabolite | Blood samples will be collected to determine Cmax of Islatravir metabolite. | At designated timepoints (up to approximately 43 days) |
| Plasma Concentration at 168 Hours (C168) of Islatravir Metabolite | Blood samples will be collected to determine the C168 of Islatravir metabolite. | At designated timepoints (up to approximately 168 hours) |
| Time to Maximum Concentration (Tmax) of Islatravir Metabolite | Blood samples will be collected to determine the Tmax of Islatravir metabolite. | At designated timepoints (up to approximately 43 days) |
| Apparent Terminal Half-life (t1/2) of Islatravir Metabolite | Blood samples will be collected to determine the t1/2 of Islatravir metabolite. | At designated timepoints (up to approximately 43 days) |
| AUC0-Inf of Islatravir |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. | Up to approximately 5 months |
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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 |
|---|---|
| C000723084 | ulonivirine |
| C558823 | islatravir |
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| Drug |
Oral administration |
|
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Blood samples will be collected to determine the AUC0-Inf of Islatravir. |
| At designated timepoints (up to approximately 22 days) |
| AUC0-168hrs of Islatravir | Blood samples will be collected to determine the AUC0-168hrs of Islatravir. | At designated timepoints (up to approximately 7 days) |
| Cmax of Islatravir | Blood samples will be collected to determine Cmax of Islatravir. | At designated timepoints (up to approximately 22 days) |
| C168 of Islatravir | Blood samples will be collected to determine the C168 of Islatravir. | At designated timepoints (up to approximately 168 hours) |
| Tmax of Islatravir | Blood samples will be collected to determine the Tmax of Islatravir. | At designated timepoints (up to approximately 22 days) |
| t1/2 of Islatravir | Blood samples will be collected to determine the t1/2 of Islatravir. | At designated timepoints (up to approximately 22 days) |
| Apparent clearance (CL/F) of Islatravir | Blood samples will be collected to determine the CL/F of Islatravir. | At designated timepoints (up to approximately 22 days) |
| Apparent Volume of Distribution During Terminal Phase (Vd/F) of Islatravir | Blood samples will be collected to determine the Vd/F of Islatravir. | At designated timepoints (up to approximately 22 days) |
| AUC0-168hrs of MK-8507 | Blood samples will be collected to determine the AUC0-168hrs of MK-8507. | At designated timepoints (up to approximately 7 days) |
| Cmax of MK-8507 | Blood samples will be collected to determine Cmax of MK-8507. | At designated timepoints (up to approximately 15 days) |
| C168 of MK-8507 | Blood samples will be collected to determine the C168 of MK-8507. | At designated timepoints (up to approximately 168 hours) |
| Tmax of MK-8507 | Blood samples will be collected to determine the Tmax of MK-8507. | At designated timepoints (up to approximately 15 days) |
| t1/2 of MK-8507 | Blood samples will be collected to determine the t1/2 of MK-8507. | At designated timepoints (up to approximately 15 days) |
| CL/F of MK-8507 | Blood samples will be collected to determine the CL/F of MK-8507. | At designated timepoints (up to approximately 15 days) |
| Vd/F of MK-8507 | Blood samples will be collected to determine the Vd/F of MK-8507. | At designated timepoints (up to approximately 15 days) |
| Number of Participants Who Discontinue Study Treatment Due to an AE |
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported. |
| Up to approximately 5 months |