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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8591A-055 | Other Identifier | MSD | |
| CA42943 | Other Identifier | Celerion |
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The purpose of this study is to learn what happens to MK-8591A in a person's body over time. Researchers will compare what happens to MK-8591A in the body when it is given with and without food.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-8591A Sequence 1A | Experimental | Participants will receive Doravine/Islatravir (DOR/ISL) fixed-dose combination (FDC) tablet under fasting conditions followed by a DOR/ISL FDC tablet under fed conditions followed by a single dose Doravine tablet and a single dose Islatravir capsule under fasting conditions. |
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| MK-8591A Sequence 2A | Experimental | Participants will receive DOR/ISL FDC tablet under fasting conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fed conditions. |
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| MK-8591A Sequence 1B | Experimental | Participants will receive DOR/ISL FDC tablet under fed conditions followed by a DOR/ISL FDC tablet under fasting conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting conditions. |
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| MK-8591A Sequence 2B | Experimental | Participants will receive DOR/ISL FDC tablet under fed conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting condition followed by a DOR/ISL FDC tablet under fasting conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8591A | Drug | Fixed dose combination tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time 0-infinity (AUC0-inf) of DOR | AUC0-inf is a measure of plasma drug concentration from time 0 to infinity and is estimated as the area under the plot of plasma concentration against time 0 to infinity after drug administration. Blood samples collected at designated time points will be used to determine the AUC0-inf of DOR. | At designated time points up to ~30 days |
| Area under the curve from time 0 to last measurable concentration (AUC0-last) of Doravine | AUC0-last is defined as the area under the concentration-time curve from time 0 to time of last measurable concentration of DOR. Blood will be collected at designated time points to determine the AUC0-last of DOR. | At designated time points up to ~30 days |
| Maximum plasma concentration (Cmax) of doravine | Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected at designated time points will be used to determine Cmax of DOR. | At designated time points up to ~30 days |
| Plasma concentration at 24 hours postdose (C24) of DOR | C24 is the concentration at 24 hours postdose of the drug observed in plasma. Blood samples collected at 24 postdose will be used to determine C24 of DOR. | At designated time points up to ~24 hours postdose |
| AUC0-inf of ISL | AUC0-inf is a measure of plasma drug concentration and time 0 to infinity and is estimated as the area under the plot of plasma concentration against time 0 to infinity after drug administration. Blood samples collected at designated time points will be used to determine the AUC0-inf of ISL. | At designated time points up to ~30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experienced an adverse event (AE) | An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants with an adverse event will be reported. |
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Inclusion Criteria:
Inclusion Criteria include, but are not limited to:
Exclusion Criteria:
Exclusion Criteria include, but are not limited to:
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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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| MK-8591A Sequence 1C | Experimental | Participants will receive a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fasting conditions followed by followed by a DOR/ISL FDC tablet under fed conditions. |
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| MK-8591A Sequence 2C | Experimental | Participants will receive a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fed conditions followed by followed by a DOR/ISL FDC tablet under fasting conditions. |
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| Islatravir | Drug | Oral capsule |
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| Doravine | Drug | Oral tablet |
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| AUC0-last of ISL |
AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of ISL. Blood will be collected at designated time points to determine the AUC0-last of ISL. |
| At designated time points up to ~30 days |
| Cmax of ISL | Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected at designated time points will be used to determine Cmax of ISL. | At designated time points up to ~30 days |
| Up to ~44 days |
| Number of participants who discontinued study intervention due to an AE | An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants who discontinue study intervention due to an AE will be reported. | Up to ~30 days |
| ID | Term |
|---|---|
| C000592662 | doravirine |
| C558823 | islatravir |
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