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PF-07940369

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 28, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06532383A Study to Learn How Different Amounts of the Study Medicine Called PF-07940369 Are Tolerated and Act in the Body in Healthy Adults.PHASE1 COMPLETED 22 — — Aug 14, 2024Jan 16, 2025Aug 28, 20251 Belgium
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Baseline (Day 0) up to 35 days after last dose of study medication
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Baseline up to Day 4
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Baseline up to Day 4
Number of Participants With Clinically Significant Change From Baseline in Telemetry Findings
Baseline up to Day 4
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Baseline up to Day 4
Secondary Endpoints
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07940369
Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Maximum Observed Plasma Concentration (Cmax) of PF-07940369
Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07940369
Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-07940369 and Placebo (Cohort 1)EXPERIMENTALSingle dose administration of PF-07940369 and placebo; Within a cohort, participants will receive up to 4 oral doses of PF-07940369 and up to 2 doses of placebo.
PF-07940369 and Placebo (Cohort 2)PLACEBO_COMPARATORSingle dose administration of PF-07940369 and placebo; Within a cohort, participants will receive up to 4 oral doses of PF-07940369 and up to 2 doses of placebo.
Interventions
NameTypeDescription
PF-07940369DRUGBulk powder for extemporaneous preparation for oral solutions.
PlaceboDRUGBulk powder for extemporaneous preparation for oral solutions
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: -Male participants and female participants who are not of childbearing potential who are overtly healthy as determined by medical evaluation including medical history, physical ex...

Countries:Belgium
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