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PF-03526299

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 22, 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 Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00990756A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult VolunteersPHASE1 COMPLETED 24 — — Nov 1, 2009Jan 1, 2010Jan 22, 20101 Singapore
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Study Endpoints
Primary Endpoints
Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.
17 days
Secondary Endpoints
Pharmacokinetic parameters: Plasma Day 1: Cmax, Tmax, AUCτau.
Day 1 - 17
Plasma Day 7: Cmax, Tmax.
7 Days
Plasma Day 14: Cmax, Tmax, CL/F, AUCτau, t½, accumulation ratio, time to steady state.
14 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-03526299 1.396 mgEXPERIMENTAL -
PF-03526299 4mgEXPERIMENTAL -
Interventions
NameTypeDescription
PF-03526299DRUGdry powder for inhalation, 1.396 mg, BID for 14 days
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Eligibility Criteria
Age Range21 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects and females of non-childbearing potential between the ages of 21 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). * Subjects who had a normal chest X-ray in the previous 6 months prior to Screening ...

Countries:Singapore
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