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PF-03049423

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 9, 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 Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01161069A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older VolunteersPHASE1 COMPLETED 48 — — Aug 1, 2009Dec 1, 2009Aug 9, 20111 Belgium
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Study Endpoints
Primary Endpoints
Safety laboratory assessments, vital signs (including supine and standing blood pressure), physical examination, 12-lead ECGs and adverse events.
Days 1 through 14
PK Parameters:Day 1: Area under concentration time curve from hour 0 to the last dosing interval (AUCtau), maximum observed concentration (Cmax), and time of maximum observed concentration (Tmax), for PF-03049423 in plasma.
Day 1
PK Parameters: Day 14: Cmax at steady state, Tmax, AUCtau at steady state , t½, Cavg at steady state, Cmin at steady state, Cmax at steady state /Cmax sd, AUCtau at steady state/ AUCtau sd, Ae% and CLr.
Day 14
Secondary Endpoints
Blood pressure
Days 1 to 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
PF-03049423ACTIVE_COMPARATORCohorts 1 through 3 were healthy young adult volunteers; cohorts 4 and 5 were healthy elderly adult volunteers
DrugPLACEBO_COMPARATORPlacebo in oral solution, given once daily for 14 days
Interventions
NameTypeDescription
PF-03049423DRUGPF-03049423 in oral solution, 2.5 mg, given once daily for 14 days; healthy young adult volunteers
PlaceboDRUGPlacebo in oral solution, given once daily for 14 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy persons, male or female. * For the healthy young adult cohort, subjects must be 18 to 50 years old, inclusive. * For the healthy elderly adult cohort, subjects must be 51 to 99 years old, inclusive. * Body Mass Index (BMI) of 18 to 35; and a total body weight \>50 kg (...

Countries:Belgium
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