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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Dolutegravir; Drug: Bictegravir/emtricitabine/tenofovir alafenamide; Drug: MK4646

Study type: Interventional

Funder types: Industry

Identifiers

NCT07532304

MK-4646-006 (Other Identifier)

4646-006

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

Treatment A: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)

Experimental group

Description:

Participants will receive a single oral dose of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).

Treatment:

Drug: Bictegravir/emtricitabine/tenofovir alafenamide

Treatment B: dolutegravir (DTG)

Experimental group

Description:

Participants will receive a single oral dose of dolutegravir (DTG).

Treatment:

Drug: Dolutegravir

Treatment C: MK-4646 + bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)

Experimental group

Description:

Participants will receive a single oral dose of MK-4646 coadministered with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).

Treatment:

Drug: MK4646

Drug: Bictegravir/emtricitabine/tenofovir alafenamide

Treatment D: MK-4646 + dolutegravir (DTG)

Experimental group

Description:

Participants will receive a single oral dose of MK-4646 coadministered with dolutegravir (DTG).

Treatment:

Drug: MK4646

Drug: Dolutegravir