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PF-05212384

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 4, 2014

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02142920Investigation Of The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male VolunteersPHASE1 COMPLETED 6Jul 1, 2014Aug 1, 2014Sep 4, 20141 United Kingdom
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
0.5 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0.5 hours
Secondary Endpoints
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
9 Days
Area under the Concentration-Time Curve (AUC)
9 days
Plasma Decay Half-Life (t1/2)
9 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
[14C] PF 05212384EXPERIMENTALReceive PF-05212384 89 mg Dose
Interventions
NameTypeDescription
PF-05212384DRUGSingle 89 mg Dose via 30 minute IV infusion
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Eligibility Criteria
Age Range30 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects between the ages of 30- 65 years vasectomised or \>40 with no desire to father children in the near future (12 months), inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examinati...

Countries:United Kingdom
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