A Study of MK-4646 with HIV-1 Medications in Healthy Adults

This study is testing a new medicine called MK-4646, which is designed to treat HIV-1 (Human Immunodeficiency Virus Type 1). Before testing new medicines in people with HIV-1, researchers first study them in healthy volunteers. This trial aims to see if taking MK-4646 together with standard HIV-1 treatments, Bictegravir/Emtricitabine/Tenofovir Alafenamide or Dolutegravir, changes how much of these HIV-1 medicines stay in the blood over time. You may be able to join if you are a healthy adult between 18 and 60 years old with a body mass index (BMI) between 18 and 32 kg/m^2. The study will be considered successful if researchers can measure the levels of Bictegravir, Emtricitabine, and Tenofovir Alafenamide in your blood at specific times after taking the medications. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 16 healthy adult participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure drug levels at designated timepoints, up to approximately 72 hours post dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07532304

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

Completed
PHASE1Ages 18–60InterventionalBasic science
Merck Sharp & Dohme LLC
~16 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Bictegravir/emtricitabine/tenofovir alafenamideDolutegravirMK4646

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Bictegravir
Measured over At designated timepoints (up to approximately 72 hours post dose)
+4 more outcomes measured
Healthy

NCT07532304

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Pinnacle Research Group ( Site 0001)

    Anniston, Alabamano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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)
  • Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of BictegravirAt designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the AUC0-∞ of bictegravir.

  • Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of EmtricitabineAt designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the AUC0-∞ of emtricitabine.

  • Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Tenofovir AlafenamideAt designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the AUC0-∞ of tenofovir alafenamide.

  • Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of TenofovirAt designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the AUC0-∞ of tenofovir.

  • Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of DolutegravirAt designated timepoints (up to approximately 72 hours post dose)

    Blood samples will be collected to determine the AUC0-∞ of dolutegravir.