Healthy
Conditions
Brief summary
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: * If taking MK 4646 together with BIC/FTC/TAF or DTG changes the amount of these ARTs in the blood over time. * About the safety of MK-4646 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.
Interventions
Single oral tablet
DRUGDolutegravir
Oral tablet
DRUGMK4646
Oral capsule
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Is in good health before randomization * Has a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive
Exclusion criteria
* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * Has a history of cancer (malignancy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Tenofovir | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the AUC0-∞ of tenofovir. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Dolutegravir | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the AUC0-∞ of dolutegravir. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Bictegravir | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the AUC0-∞ of bictegravir. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Emtricitabine | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the AUC0-∞ of emtricitabine. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Tenofovir Alafenamide | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the AUC0-∞ of tenofovir alafenamide. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Terminal Half-life (t½) of Tenofovir | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the t½ of tenofovir. |
| Maximum Plasma Concentration (Cmax) of Dolutegravir | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the Cmax of dolutegravir. |
| Plasma Concentration at (C24) of Dolutegravir | 24 hours post dose | Blood samples will be collected to determine the C24 of dolutegravir. |
| Time to Maximum Plasma Concentration (Tmax) of Dolutegravir | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the Tmax of dolutegravir. |
| Apparent Terminal Half-life (t½) of Dolutegravir | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the t½ of dolutegravir. |
| Time to Maximum Plasma Concentration (Tmax) of Emtricitabine | At designated time points (up to approximately 72 hours post dose) | Blood samples will be collected to determine the Tmax of emtricitabine. |
| Apparent Terminal Half-life (t½) of Emtricitabine | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the t½ of emtricitabine. |
| Maximum Plasma Concentration (Cmax) of Tenofovir Alafenamide | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the Cmax of tenofovir alafenamide. |
| Plasma Concentration at 24 Hours (C24) of Tenofovir Alafenamide | At designated time points (up to approximately 24 hours post dose) | Blood samples will be collected to determine the C24 of tenofovir alafenamide. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 44 days | 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. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 31 Days | 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. |
| Maximum Plasma Concentration (Cmax) of Bictegravir | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the Cmax of bictegravir. |
| Plasma Concentration at 24 Hours (C24) of Bictegravir | 24 hours post dose | Blood samples will be collected to determine the C24 of bictegravir. |
| Time to Maximum Plasma Concentration (Tmax) of Bictegravir | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the Tmax of bictegravir. |
| Apparent Terminal Half-life (t½) of Bictegravir | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the t½ of bictegravir. |
| Maximum Plasma Concentration (Cmax) of Emtricitabine | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the Cmax of emtricitabine. |
| Time to Maximum Plasma Concentration (Tmax) of Tenofovir Alafenamide | At designated time points (up to approximately 72 hours post dose) | Blood samples will be collected to determine the Tmax of tenofovir alafenamide. |
| Plasma Concentration at 24 Hours (C24) of Emtricitabine | 24 hours post dose | Blood samples will be collected to determine the C24 of emtricitabine. |
| Apparent Terminal Half-life (t½) of Tenofovir Alafenamide | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the t½ of tenofovir alafenamide. |
| Maximum Plasma Concentration (Cmax) of Tenofovir | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the Cmax of tenofovir. |
| Plasma Concentration at (C24) of Tenofovir | 24 hours post dose | Blood samples will be collected to determine the C24 of tenofovir. |
| Time to Maximum Plasma Concentration (Tmax) of Tenofovir | At designated timepoints (up to approximately 72 hours post dose) | Blood samples will be collected to determine the Tmax of tenofovir. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed