Actively Recruiting
A Drug-Drug Interaction Study of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adults
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-26
16
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) 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 BIC/FTC/TAF alone, DTG alone, MK-4646 combined with BIC/FTC/TAF, 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.
CONDITIONS
Brief Title
A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Is in good health before randomization
- Has a body mass index (BMI) between 18 and 32 kg/m2, inclusive
- Is between 18 and 60 years old
You will not qualify if you...
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological diseases
- Has a history of cancer (malignancy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 72 hours per treatment period
Participants receive single oral doses of study drugs in a crossover design to evaluate drug interactions.
Multiple visits for each dosing period up to 72 hours post dose
Duration - Up to approximately 44 days
Participants are monitored for adverse events and safety up to approximately 44 days after treatment.
Visits as needed for safety monitoring during follow-up
Trial Site Locations
Total: 1 location
1
Pinnacle Research Group ( Site 0001)
Anniston, Alabama, United States, 36207
Actively Recruiting
Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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