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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• Is in good health before randomization

• Has a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive

Locations
United States
Alabama
Pinnacle Research Group ( Site 0001)
RECRUITING
Anniston
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2026-05-11
Estimated Completion Date: 2026-07-21
Participants
Target number of participants: 16
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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