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PF-05221304 Formulation A

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: May 20, 2020

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 Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03871439OPEN LABEL, 2-PERIOD STUDY, TO COMPARE BIO-AVAILABILITY OF 2 DIFFERENT FORMULATIONS OF PF-05221304 IN HEALTHY ADULTSPHASE1 COMPLETED 10Mar 13, 2019May 8, 2019May 20, 20201 United States
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Study Endpoints
Primary Endpoints
Plasma PF-05221304 AUClast
Thirteen timepoints between 0-72 Hours

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Plasma PF-05221304 Cmax
Thirteen timepoints between 0-72 Hours

Maximum Observed Plasma Concentration (Cmax)

Secondary Endpoints
Number of Subjects Experiencing an Adverse Event
Up to 10 weeks from screening
Number of Participants With Clinical Laboratory Abnormalities
Up to 10 weeks from screening
Number of Participants With Categorical Vital Signs Data
Up to 10 weeks from screening
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-05221304 Formulation AEXPERIMENTAL -
PF-05221304 Formulation BEXPERIMENTAL -
Interventions
NameTypeDescription
PF-05221304 Formulation ADRUG50mg
PF-05221304 Formulation BDRUG50mg
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Ages of 18 and 55 years old inclusive * Body Mass Index (BMI) of \>= 17.5 and \<= 30.4 kg/m2 * Total body weight \> 50 kg (110lb) Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular,...

Countries:United States
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