Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-4646-006 | Other Identifier | MSD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Researchers are looking for new treatments for people living with HIV-1(Human Immunodeficiency Virus Type 1). HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system.
HIV-1 treatments, called ART (antiretroviral therapy), involve taking medicines to lower the amount of HIV-1 virus in the body. Standard ART may include Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) and Dolutegravir (DTG).
MK-4646 is a trial medicine designed to treat HIV-1. Before giving a trial medicine to people with a health condition, researchers first do trials in healthy people.
The goals of this study are to learn:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) | Experimental | Participants will receive a single oral dose of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). |
|
| Treatment B: dolutegravir (DTG) | Experimental | Participants will receive a single oral dose of dolutegravir (DTG). |
|
| Treatment C: MK-4646 + bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) | Experimental | Participants will receive a single oral dose of MK-4646 coadministered with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). |
|
| Treatment D: MK-4646 + dolutegravir (DTG) | Experimental | Participants will receive a single oral dose of MK-4646 coadministered with dolutegravir (DTG). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bictegravir/emtricitabine/tenofovir alafenamide | Drug | Single oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Bictegravir | Blood samples will be collected to determine the AUC0-∞ of bictegravir. | At designated timepoints (up to approximately 72 hours post dose) |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Emtricitabine | Blood samples will be collected to determine the AUC0-∞ of emtricitabine. | At designated timepoints (up to approximately 72 hours post dose) |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Tenofovir Alafenamide | Blood samples will be collected to determine the AUC0-∞ of tenofovir alafenamide. | At designated timepoints (up to approximately 72 hours post dose) |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Tenofovir | Blood samples will be collected to determine the AUC0-∞ of tenofovir. | At designated timepoints (up to approximately 72 hours post dose) |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Dolutegravir | Blood samples will be collected to determine the AUC0-∞ of dolutegravir. | At designated timepoints (up to approximately 72 hours post dose) |
| 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 44 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group ( Site 0001) | Anniston | Alabama | 36207 | United States |
Not provided
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dolutegravir | Drug | Oral tablet |
|
| MK4646 | Drug | Oral capsule |
|
| 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 31 Days |
| Maximum Plasma Concentration (Cmax) of Bictegravir | Blood samples will be collected to determine the Cmax of bictegravir. | At designated timepoints (up to approximately 72 hours post dose) |
| Plasma Concentration at 24 Hours (C24) of Bictegravir | Blood samples will be collected to determine the C24 of bictegravir. | 24 hours post dose |
| Time to Maximum Plasma Concentration (Tmax) of Bictegravir | Blood samples will be collected to determine the Tmax of bictegravir. | At designated timepoints (up to approximately 72 hours post dose) |
| Apparent Terminal Half-life (t½) of Bictegravir | Blood samples will be collected to determine the t½ of bictegravir. | At designated timepoints (up to approximately 72 hours post dose) |
| Maximum Plasma Concentration (Cmax) of Emtricitabine | Blood samples will be collected to determine the Cmax of emtricitabine. | At designated timepoints (up to approximately 72 hours post dose) |
| Plasma Concentration at 24 Hours (C24) of Emtricitabine | Blood samples will be collected to determine the C24 of emtricitabine. | 24 hours post dose |
| Time to Maximum Plasma Concentration (Tmax) of Emtricitabine | Blood samples will be collected to determine the Tmax of emtricitabine. | At designated time points (up to approximately 72 hours post dose) |
| Apparent Terminal Half-life (t½) of Emtricitabine | Blood samples will be collected to determine the t½ of emtricitabine. | At designated timepoints (up to approximately 72 hours post dose) |
| Maximum Plasma Concentration (Cmax) of Tenofovir Alafenamide | Blood samples will be collected to determine the Cmax of tenofovir alafenamide. | At designated timepoints (up to approximately 72 hours post dose) |
| Plasma Concentration at 24 Hours (C24) of Tenofovir Alafenamide | Blood samples will be collected to determine the C24 of tenofovir alafenamide. | At designated time points (up to approximately 24 hours post dose) |
| Time to Maximum Plasma Concentration (Tmax) of Tenofovir Alafenamide | Blood samples will be collected to determine the Tmax of tenofovir alafenamide. | At designated time points (up to approximately 72 hours post dose) |
| Apparent Terminal Half-life (t½) of Tenofovir Alafenamide | Blood samples will be collected to determine the t½ of tenofovir alafenamide. | At designated timepoints (up to approximately 72 hours post dose) |
| Maximum Plasma Concentration (Cmax) of Tenofovir | Blood samples will be collected to determine the Cmax of tenofovir. | At designated timepoints (up to approximately 72 hours post dose) |
| Plasma Concentration at (C24) of Tenofovir | Blood samples will be collected to determine the C24 of tenofovir. | 24 hours post dose |
| Time to Maximum Plasma Concentration (Tmax) of Tenofovir | Blood samples will be collected to determine the Tmax of tenofovir. | At designated timepoints (up to approximately 72 hours post dose) |
| Apparent Terminal Half-life (t½) of Tenofovir | Blood samples will be collected to determine the t½ of tenofovir. | At designated timepoints (up to approximately 72 hours post dose) |
| Maximum Plasma Concentration (Cmax) of Dolutegravir | Blood samples will be collected to determine the Cmax of dolutegravir. | At designated timepoints (up to approximately 72 hours post dose) |
| Plasma Concentration at (C24) of Dolutegravir | Blood samples will be collected to determine the C24 of dolutegravir. | 24 hours post dose |
| Time to Maximum Plasma Concentration (Tmax) of Dolutegravir | Blood samples will be collected to determine the Tmax of dolutegravir. | At designated timepoints (up to approximately 72 hours post dose) |
| Apparent Terminal Half-life (t½) of Dolutegravir | Blood samples will be collected to determine the t½ of dolutegravir. | At designated timepoints (up to approximately 72 hours post dose) |
| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
| C562325 | dolutegravir |
Not provided
Not provided
Not provided