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PF-06414300

Phase 1

Healthy Participants | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 1, 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_CONTROLLED
Total Trials1
Total Enrollment63
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06659250A Study to Learn How Different Amounts and Forms of the Study Medicine Called PF-06414300 Act in Healthy AdultsPHASE1 COMPLETED 63 — — Sep 27, 2024Aug 22, 2025Oct 1, 20251 United States
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Study Endpoints
Primary Endpoints
Number of Adverse Events (AE) observed after single or multiple doses
Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Number of Serious AE observed after single or multiple doses
Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Number of participants with abnormal vital sign changes following single or multiple ascending doses
Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Number of Participants with Electrocardiogram (ECG) Abnormalities including QT and QTcF interval following single or multiple ascending dose
Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Number of participants with clinically significant laboratory values
Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Secondary Endpoints
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Part A
Day 1 up to Day 4 (Part A)
Maximum Observed Plasma Concentration (Cmax) Part A
Day 1 up to Day 4 (Part A)
Time to Reach Maximum Observed Plasma Concentration (Tmax) Part A
Day 1 up to Day 4 (Part A)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-06414300EXPERIMENTALParticipants will receive single or multiple ascending oral doses of PF-06414300
PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo.
Interventions
NameTypeDescription
PF-06414300DRUGParticipants will receive oral ascending doses.
PlaceboDRUGParticipants will receive matching placebo.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass Index (BMI) of 16-32 kg/m2; and a total body weight \>50 kg (110 lb). * Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs assessments, 12-lead ECGs a...

Countries:United States
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