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Bictegravir/emtricitabine/tenofovir alafenamide

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Aug 25, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Bictegravir/emtricitabine/tenofovir alafenamide · 1 trial · 1 indication

Phase 1 1
NCT07532304A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646)Healthy
COMPLETED16 Analytics
PHASE1COMPLETED
A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646)
Healthy
NCT0753230416
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Study Endpoints

Primary Endpoints

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Bictegravir
At 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 Emtricitabine
At 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 Alafenamide
At 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 Tenofovir
At 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 Dolutegravir
At designated timepoints (up to approximately 72 hours post dose)

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

Secondary Endpoints

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)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment A: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)EXPERIMENTALParticipants will receive a single oral dose of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
Treatment B: dolutegravir (DTG)EXPERIMENTALParticipants will receive a single oral dose of dolutegravir (DTG).
Treatment C: MK-4646 + bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)EXPERIMENTALParticipants will receive a single oral dose of MK-4646 coadministered with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
Treatment D: MK-4646 + dolutegravir (DTG)EXPERIMENTALParticipants will receive a single oral dose of MK-4646 coadministered with dolutegravir (DTG).

Interventions

NameTypeDescription
Bictegravir/emtricitabine/tenofovir alafenamideDRUGSingle oral tablet
DolutegravirDRUGOral tablet
MK4646DRUGOral capsule
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Recent Changes (Last 90 Days)

HIGHAug 25, 2026NCT07532304Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHAug 25, 2026NCT07532304Status: ACTIVE_NOT_RECRUITING → COMPLETED
MEDIUMJun 24, 2026NCT07532304Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 24, 2026NCT07532304Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about Bictegravir/emtricitabine/tenofovir alafenamide

What is bictegravir/emtricitabine/tenofovir alafenamide used for?

Bictegravir/emtricitabine/tenofovir alafenamide is a small molecule drug being studied in healthy adult participants. It is currently in Phase 1 clinical development and is not approved for any indication. The drug is being investigated in a clinical trial in the United States.

Who makes bictegravir/emtricitabine/tenofovir alafenamide?

Bictegravir/emtricitabine/tenofovir alafenamide is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this drug in healthy volunteers.

What phase is bictegravir/emtricitabine/tenofovir alafenamide in?

Bictegravir/emtricitabine/tenofovir alafenamide is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is bictegravir/emtricitabine/tenofovir alafenamide in?

Bictegravir/emtricitabine/tenofovir alafenamide has one completed clinical trial, NCT07532304, titled "A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646)." The trial enrolled 16 healthy adults in the United States.

Is bictegravir/emtricitabine/tenofovir alafenamide the same as MK-4646?

Bictegravir/emtricitabine/tenofovir alafenamide is being studied in combination with MK-4646, as indicated by the clinical trial title. The trial evaluates the drug alongside MK-4646 and dolutegravir in healthy participants.