Recent Updates
Recently added Catalysts

PF-3864086

Phase 1

Pain | Small molecule | Pain |Pfizer, Inc.|Last Updated: Jan 8, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00747058A Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-03864086 In Healthy Male SubjectsPHASE1 COMPLETED 28Aug 1, 2008Dec 1, 2008Jan 8, 20101 Belgium
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Pharmacokinetics
measured intensively in the first 48 hours and continue out to day 14
Tolerability
measured intensively in the first 48 hours and continue out to day 14
Secondary Endpoints
Temperature change
continuous recording over the first 48h post dose
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
healthy volunteersEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-3864086DRUGThe dosage form is POS (powdered oral suspension). Each subject will have 5 periods and the frequency (and duration) is once per period. The doses have been left flexible within the protocol but are listed as: 3, 10, 30, 60, 120, 240, 480 and 720 mg with an option to insert an additional dose cohort as well.
PlaceboDRUGPlacebo
Unlock Study Design Details
Eligibility Criteria
Age Range21 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * healthy male volunteers * no drug history * no other medication for 28 pre-dose Exclusion Criteria: * age below 21 years * age above 55 years

Countries:Belgium
Unlock Eligibility Criteria