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Bictegravir/emtricitabine/tenofovir alafenamide

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: May 26, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLED
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07532304A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646)PHASE1 RECRUITING 16 — — May 11, 2026Jul 21, 2026May 26, 20261 United States
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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 — 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)
LOWMay 27, 2026NCT07532304lastUpdatePostDate: changed
LOWMay 27, 2026NCT07532304lastUpdatePostDate: changed
LOWMay 24, 2026NCT07532304studyFirstPostDate: changed
LOWMay 21, 2026NCT07532304NEW_TRIAL: changed
LOWMay 21, 2026NCT07532304NEW_TRIAL: changed