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

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07532304
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Bictegravir/emtricitabine/tenofovir alafenamide — DRUG
    Single oral tablet
  • Dolutegravir — DRUG
    Oral tablet
  • MK4646 — DRUG
    Oral capsule

Study Details

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.

Key Dates

Start date
May 11, 2026
Status verified
May 2026
Primary completion
Jul 21, 2026
Completion
Jul 21, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment A: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)
    Participants will receive a single oral dose of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
  • Experimental: Treatment B: dolutegravir (DTG)
    Participants will receive a single oral dose of dolutegravir (DTG).
  • Experimental: Treatment C: MK-4646 + bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)
    Participants will receive a single oral dose of MK-4646 coadministered with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
  • Experimental: Treatment D: MK-4646 + dolutegravir (DTG)
    Participants will receive a single oral dose of MK-4646 coadministered with dolutegravir (DTG).

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group ( Site 0001)AnnistonAlabama36207
Study Coordinator
256-236-0055

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By research site
Pinnacle Research Group· Anniston, AL

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