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PF-05175157

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Jul 10, 2012

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_CONTROLLEDBiomarker
Total Trials2
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01537497A Study To Evaluate The Effects Of PF-05175157 In Healthy VolunteersPHASE1 COMPLETED 31Mar 1, 2012May 1, 2012Jul 10, 20121 United States
NCT01433380A Study To Evaluate PF-05175157 In Healthy VolunteersPHASE1 COMPLETED 22Jul 1, 2011May 1, 2012May 18, 20121 United States
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Study Endpoints
Primary Endpoints
Modulation of carbohydrate and lipid metabolism
24 hours
Changes in carbohydrate and lipid metabolism
24 hours
Secondary Endpoints
Cmax of PF-05175157 after single oral doses
24 hours
Tmax of PF-05175157 after single oral doses
24 hours
Area under the curve (AUC) of PF-05175157 after single oral doses
24 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
100 mg PF-05175157EXPERIMENTALThe chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
250 mg PF-05175157EXPERIMENTALThe chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
600 mg PF-05175157EXPERIMENTALThe chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
PlaceboPLACEBO_COMPARATORThe chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
Interventions
NameTypeDescription
PF-05175157DRUGOne single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.
PlaceboDRUGOne single oral dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects 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 pulse rate measurement, 12 lead EC...

Countries:United States
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