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

NCT07532304 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 4646-006MK-4646-006
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Bictegravir

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

  At designated timepoints (up to approximately 72 hours post dose)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Emtricitabine

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

  At designated timepoints (up to approximately 72 hours post dose)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tenofovir

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

  At designated timepoints (up to approximately 72 hours post dose)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Dolutegravir

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

  At designated timepoints (up to approximately 72 hours post dose)

Secondary Outcomes (18)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 44 days

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 31 Days

• Maximum Plasma Concentration (Cmax) of Bictegravir

  At designated timepoints (up to approximately 72 hours post dose)

• Plasma Concentration at 24 Hours (C24) of Bictegravir

  At designated time points (up to approximately 24 hours post dose)

• Time to Maximum Plasma Concentration (Tmax) of Bictegravir

  At designated timepoints (up to approximately 72 hours post dose)

Study Arms (4)

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

EXPERIMENTAL

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

Drug: Bictegravir/emtricitabine/tenofovir alafenamide

Treatment B: dolutegravir (DTG)

EXPERIMENTAL

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

Drug: Dolutegravir

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

EXPERIMENTAL

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

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

Treatment D: MK-4646 + dolutegravir (DTG)

EXPERIMENTAL

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

Drug: Dolutegravir; Drug: MK4646

Interventions

Bictegravir/emtricitabine/tenofovir alafenamide DRUG

Single oral tablet

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

Dolutegravir DRUG

Oral tablet

Treatment B: dolutegravir (DTG); Treatment D: MK-4646 + dolutegravir (DTG)

MK4646 DRUG

Oral capsule

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination; dolutegravir

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): July 13, 2026
• Study Completion (Estimated): July 13, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share