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PF-03715455

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 12, 2011

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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01186757Multiple Dose Healthy Volunteer Study of PF-03715455.PHASE1 COMPLETED 36 — — Aug 1, 2010Jan 1, 2011Jan 12, 20111 Singapore
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Study Endpoints
Primary Endpoints
Pharmacokinetics of single and multiple inhaled doses of PF-03715455, as measured by plasma concentrations - Cmax, Tmax, AUCtau, t½, accumulation ratio (Rac, Rss, Rac,Cmax).
17 days
Secondary Endpoints
Safety and toleration as measured by adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.
28 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
PF-03715455 1.6mg BIDACTIVE_COMPARATOR -
PF-03715455 4 mg BIDACTIVE_COMPARATOR -
PF-03715455 10 mg BIDACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-03715455DRUGPF-03715455 1.6 mg BID
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range21 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteers Exclusion Criteria: * Standard healthy volunteer criteria

Countries:Singapore
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