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NCT Number: NCT07532304

A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pinnacle Research Group ( Site 0001)

Anniston, Alabama, 36207, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

bictegravir/emtricitabine/tenofovir alafenamide

Drug

Single oral tablet

Dolutegravir

Drug

Oral tablet

MK4646

Drug

Oral capsule

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Bictegravir

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the AUC0-∞ of bictegravir.

  2. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Emtricitabine

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the AUC0-∞ of emtricitabine.

  3. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Tenofovir Alafenamide

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the AUC0-∞ of tenofovir alafenamide.

  4. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Tenofovir

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the AUC0-∞ of tenofovir.

  5. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Dolutegravir

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the AUC0-∞ of dolutegravir.

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: 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.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: 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.

  3. Maximum Plasma Concentration (Cmax) of Bictegravir

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the Cmax of bictegravir.

  4. Plasma Concentration at 24 Hours (C24) of Bictegravir

    Time frame: 24 hours post dose

    Blood samples will be collected to determine the C24 of bictegravir.

  5. Time to Maximum Plasma Concentration (Tmax) of Bictegravir

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the Tmax of bictegravir.

  6. Apparent Terminal Half-life (t½) of Bictegravir

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the t½ of bictegravir.

  7. Maximum Plasma Concentration (Cmax) of Emtricitabine

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the Cmax of emtricitabine.

  8. Plasma Concentration at 24 Hours (C24) of Emtricitabine

    Time frame: 24 hours post dose

    Blood samples will be collected to determine the C24 of emtricitabine.

  9. Time to Maximum Plasma Concentration (Tmax) of Emtricitabine

    Time frame: At designated time points (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the Tmax of emtricitabine.

  10. Apparent Terminal Half-life (t½) of Emtricitabine

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the t½ of emtricitabine.

  11. Maximum Plasma Concentration (Cmax) of Tenofovir Alafenamide

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the Cmax of tenofovir alafenamide.

  12. Plasma Concentration at 24 Hours (C24) of Tenofovir Alafenamide

    Time frame: At designated time points (up to approximately 24 hours post dose)

    Blood samples will be collected to determine the C24 of tenofovir alafenamide.

  13. Time to Maximum Plasma Concentration (Tmax) of Tenofovir Alafenamide

    Time frame: At designated time points (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the Tmax of tenofovir alafenamide.

  14. Apparent Terminal Half-life (t½) of Tenofovir Alafenamide

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the t½ of tenofovir alafenamide.

  15. Maximum Plasma Concentration (Cmax) of Tenofovir

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the Cmax of tenofovir.

  16. Plasma Concentration at (C24) of Tenofovir

    Time frame: 24 hours post dose

    Blood samples will be collected to determine the C24 of tenofovir.

  17. Time to Maximum Plasma Concentration (Tmax) of Tenofovir

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the Tmax of tenofovir.

  18. Apparent Terminal Half-life (t½) of Tenofovir

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the t½ of tenofovir.

  19. Maximum Plasma Concentration (Cmax) of Dolutegravir

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the Cmax of dolutegravir.

  20. Plasma Concentration at (C24) of Dolutegravir

    Time frame: 24 hours post dose

    Blood samples will be collected to determine the C24 of dolutegravir.

  21. Time to Maximum Plasma Concentration (Tmax) of Dolutegravir

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the Tmax of dolutegravir.

  22. Apparent Terminal Half-life (t½) of Dolutegravir

    Time frame: At designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the t½ of dolutegravir.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Drug-Drug Interaction Study of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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