RecruitingPhase 1NCT07532304

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

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


Sponsor

Merck Sharp & Dohme LLC

Enrollment

16 participants

Start Date

May 11, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria2

  • Is in good health before randomization
  • Has a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive

Exclusion Criteria2

  • 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)

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Interventions

DRUGBictegravir/emtricitabine/tenofovir alafenamide

Single oral tablet

DRUGDolutegravir

Oral tablet

DRUGMK4646

Oral capsule


Locations(1)

Pinnacle Research Group

Anniston, Alabama, United States

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NCT07532304


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