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PF-04418948

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 25, 2010

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-BlindCONTROLLED
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01002963A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy VolunteersPHASE1 COMPLETED 56 — — Sep 1, 2009Feb 1, 2010Oct 25, 20101 Belgium
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Study Endpoints
Primary Endpoints
Plasma pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCtau, AUCinf, Cav, CL/F, V/F, t1/2
240 hours
Safety: Adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood safety tests, fecal occult blood (FOB), cardiac troponin measurements, urine safety tests (KIM-1 measurements and creatinine).
240 hours
Secondary Endpoints
Pharmacodynamics: Emax (maximum observed increase in TNFα concentration from pre-dose level) TEmax (time to Emax), AUEClast, AUECt (where t will be a defined timepoint) and maximum n-fold increase in concentration from pre-dose level.
48 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-04418948 30 mgEXPERIMENTAL -
PF-04418948 100 mgEXPERIMENTAL -
PF-04418948 300 mgEXPERIMENTAL -
PF-04418948 1000 mgEXPERIMENTAL -
PF-04418948 3000 mgEXPERIMENTAL -
PF-04418948 4500 mgEXPERIMENTAL -
PF-04418948 6000 mgEXPERIMENTAL -
Interventions
NameTypeDescription
PF-04418948DRUGsolution, 30 mg, single
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 55 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointest...

Countries:Belgium
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