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PF-03893787

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 18, 2010

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-BlindCONTROLLED
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00992342A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03893787 In Healthy Adult VolunteersPHASE1 COMPLETED 36 — — Nov 1, 2009Mar 1, 2010Mar 18, 20101 Belgium
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Study Endpoints
Primary Endpoints
Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood (including creatine kinase) and urine safety tests and physical examination.
22 days
Secondary Endpoints
Pharmacokinetic parameters: Cmax, Tmax, AUCτ, t½, accumulation ratio,
22 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-03893787 5 mgEXPERIMENTAL -
PF-03893787 15 mgEXPERIMENTAL -
PF-03893787 50 mgEXPERIMENTAL -
Interventions
NameTypeDescription
PF-03893787DRUGoral solution, 5 mg, QD for 14 days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects and females of non-childbearing potential between the ages of 18 and 55 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Evidence or history of clinically significant hematological,...

Countries:Belgium
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