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PF-07976016 Formulation A

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 22, 2025

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06670170A Study to Learn How Different Forms of the Study Medicine Called PF-07976016 Are Taken Up Into the Blood in Healthy AdultsPHASE1 COMPLETED 12 — — Nov 5, 2024Jan 17, 2025Sep 22, 20251 United States
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Study Endpoints
Primary Endpoints
Area Under the Curve - infinity - AUCinf (as data permit, otherwise AUClast).
Day 1 Hour 0 (pre-dose) through 168 hours post dose in each period
Secondary Endpoints
Incidence of Treatment Emergent Adverse Events - TEAEs
From first dose (Day 1) up to 28-35 days after final dose; a total of approximately 51 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Sequence 1EXPERIMENTALParticipants will receive a single dose of PF-07976016 in up to 3 study periods. In sequence 1, participants will receive formulation A followed by formulation B. There will be 7 days between each dose as a wash out period.
Sequence 2EXPERIMENTALParticipants will receive single doses of PF-07976016 in up to 3 study periods. In sequence 2, participants will receive formulation B followed by formulation A. There will be 7 days between each dose as a wash out period.
Interventions
NameTypeDescription
PF-07976016 Formulation ADRUGPF-07976016; formulation A - current/reference
PF-07976016 Formulation BDRUGPF-07976016; Formulation B - new/test
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG assessments. * Willing to provide consent and follow study requirements * Total body weight \>110lbs (50kg) Key Exclusion Criteria: ...

Countries:United States
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