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PF-04457845, FAAH inhibitor

Phase 1

Acute Pain | Small molecule | Pain |Pfizer, Inc.|Last Updated: Aug 6, 2009

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00836082A Multiple Dose Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04457845 in Healthy VolunteersPHASE1 COMPLETED 41Feb 1, 2009Jul 1, 2009Aug 6, 20091 Singapore
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Study Endpoints
Primary Endpoints
To characterize the multiple-dose pharmacokinetics of PF-04457845.
14 Days
To characterize the relationship between PF-04457845 and the level of anandamide and level of FAAH enzyme inhibition in healthy adult volunteers following multiple dosing.
14 Days
To evaluate the safety and tolerability of multiple oral doses of PF-04457845.
14 Days
To determine the effect on food on PF-04457845 pharmacokinetics following administration of single doses of 4mg and 8mg.
7-14 Days
To determine the effect on food on PF-04457845 safety following administration of single doses of 4mg and 8mg.
7-14 Days
Secondary Endpoints
CogState/GMLT
14 Days
Telemetry
14 Days
Neurologic Exam
14 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
Cohort 1 (N=10)EXPERIMENTALPlacebo-controlled, escalating multiple doses of 0.5mg per day for 14 days.
Cohort 2 (N=10)EXPERIMENTALPlacebo-controlled, escalating multiple doses of 1mg per day for 14 days.
Cohort 3 (N=10)EXPERIMENTALPlacebo-controlled, escalating multiple doses of 4mg per day for 14 days.
Cohort 4 (N=10)EXPERIMENTALPlacebo-controlled, escalating multiple doses of 8mg per day for 14 days.
Interventions
NameTypeDescription
PF-04457845, FAAH inhibitorDRUGOral solution of 0.5mg given once daily for 14 days.
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Eligibility Criteria
Age Range21 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects (of non childbearing potential) between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and puls...

Countries:Singapore
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