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PF-05186462

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 24, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01165736To Calculate the Pharmacokinetics (Concentration of Compound in and Rate of Excretion From the Blood) Following a Very Low Dose of Compound Which Will Not Have Any Pharmacological ActivityPHASE1 COMPLETED 40Jul 1, 2010Aug 1, 2010Aug 24, 20101 United Kingdom
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Study Endpoints
Primary Endpoints
Safety and tolerability (heart rate, blood pressure, QTcF, clinical chemistry)
up to 3 days post dose
pharmacokinetics of each of the four compounds measuring Clearance, volume of distribution, elimination half life and area under the effect curve
up to 3 days post dose
Secondary Endpoints
safety and tolerability of each of the four compounds (heart rate, blood pressure, QTcF, clinical chemistry)
up to 3 days post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Intravenous: PF-05186462ACTIVE_COMPARATOR -
Oral: PF-05186462ACTIVE_COMPARATOR -
Intravenous: PF-05089771ACTIVE_COMPARATOR -
Oral: PF-05089771ACTIVE_COMPARATOR -
Intravenous: PF-05150122ACTIVE_COMPARATOR -
Oral: PF-05150122ACTIVE_COMPARATOR -
Intravenous: PF-05241328ACTIVE_COMPARATOR -
Oral: PF-05241328ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
PF-05186462DRUGsingle intravenous infusion of 100 microgram
PF-05089771DRUGsingle intravenous infusion of 100 microgram of PF-05089771
PF-05150122DRUGsingle intravenous administration of 100 microgram PF-05150122
PF-05241328DRUGsingle intravenous infusion of 100 microgram PF-05241328
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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 50 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 ECG and clinical la...

Countries:United Kingdom
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