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Not yet recruiting Phase 1 NCT07532304

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

Phase 1 – testing safety in a small group of people
Conditions: Healthy

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
Who can participate
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)
Interventions
Bictegravir/emtricitabine/tenofovir alafenamide
DRUG
Dolutegravir
DRUG
MK4646
DRUG
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
60 Years
Healthy volunteers
No
Start date
11.05.2026
Completion date
21.07.2026
Registry ID
NCT07532304
Source
clinicaltrials.gov
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