A Drug-Drug Interaction Study of MK-4646 With BictegravirEmtricitabineTenofovir Alafenamide and Dolutegravir in Healthy Adults

What this Trial Is About

Researchers are investigating new treatment options for people living with HIV-1, the most common type of HIV that attacks the immune system. This Phase 1 trial aims to study MK-4646, an experimental drug, to see how it interacts with standard HIV treatments called antiretroviral therapy ART, including BictegravirEmtricitabineTenofovir Alafenamide BICFTCTAF and Dolutegravir DTG. The study also evaluates the safety and tolerability of MK-4646 when taken with these treatments. Participants will be randomly assigned to receive a single oral dose of either BICFTCTAF alone, DTG alone, MK-4646 combined with BICFTCTAF, or MK-4646 combined with DTG. The study will monitor how the levels of these medicines change in the blood over time to understand any drug interactions. All treatments are given as oral tablets or capsules in a controlled setting. During the trial, participants will undergo blood tests at specific times up to approximately 72 hours after dosing to measure drug concentrations. Researchers will track the area under the concentration-time curve AUC and other pharmacokinetic measures for each drug. Safety will be monitored for up to 44 days by recording any adverse events and reasons for stopping treatment. Total participation time varies but includes follow-up visits to assess tolerance and effects.

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