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PF-05190457

Phase 1

Diabetes Mellitus, Type II | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Jul 6, 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 Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01247896Single Dose Escalation Study of PF-05190457 in Healthy VolunteersPHASE1 COMPLETED 26 — — Dec 1, 2010Jun 1, 2011Jul 6, 20111 Belgium
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Study Endpoints
Primary Endpoints
Safety and tolerability of PF-05190457 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements
8 weeks
The single dose PK of PF-05190457 will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), as the data permit
48 hour
Secondary Endpoints
PK of PF-05190457 in the fed condition will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2),
48 hour
Gastric half-emptying time (GET½), the duration of the lag phase (Tlag), gastric emptying coefficient (GEC)
Day 1 for Periods 1 and 2, for Cohort 3.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ActiveEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-05190457DRUGSingle Dose 2 mg
PlaceboDRUGSingle Dose Placebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males and females (non-childbearing) between the ages of 18 and 55 with BMI of 17.5 to 30.5 kg/m2; and a total body weight between 50 kg (110 lbs) and 100 kg (220 lb) inclusive Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, ...

Countries:Belgium
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