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

Purpose

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.

Condition

  • Healthy

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment A: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) 		Participants will receive a single oral dose of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
  • Drug: Bictegravir/emtricitabine/tenofovir alafenamide
    Single oral tablet
Experimental
Treatment B: dolutegravir (DTG) 		Participants will receive a single oral dose of dolutegravir (DTG).
  • Drug: Dolutegravir
    Oral tablet
Experimental
Treatment C: MK-4646 + bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) 		Participants will receive a single oral dose of MK-4646 coadministered with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
  • Drug: Bictegravir/emtricitabine/tenofovir alafenamide
    Single oral tablet
  • Drug: MK4646
    Oral capsule
Experimental
Treatment D: MK-4646 + dolutegravir (DTG) 		Participants will receive a single oral dose of MK-4646 coadministered with dolutegravir (DTG).
  • Drug: Dolutegravir
    Oral tablet
  • Drug: MK4646
    Oral capsule

Recruiting Locations

Pinnacle Research Group ( Site 0001)
Anniston, Alabama 36207
Contact:
Study Coordinator
256-236-0055

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com