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PF-06273588

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 9, 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
RandomizedCONTROLLED
Total Trials1
Total Enrollment5
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01408355A Study To Investigate The Elimination Of PF-06273588 From The Body Following A Single Low Dose.PHASE1 COMPLETED 5Jul 1, 2011Aug 1, 2011Sep 9, 20111 United Kingdom
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Study Endpoints
Primary Endpoints
The number of participants with Adverse Events as a measure of Safety and tolerability.
3 days
Pharmacokinetics : peak plasma concentration
3 days
Pharmacokinetics : time of peak plasma concentration
3 days
Pharmacokinetics : area under plasma concentration-time curve
3 days
Pharmacokinetics : Terminal plasma half life
3 days
Pharmacokinetics : Plasma Clearance
3 days
Pharmacokinetics : plasma volume of distribution
3 days
Pharmacokinetics : oral bioavailability
3 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
50 microgram PF-06273588 intravenousEXPERIMENTALSubjects will receive a single intravenous microdose of PF-06273588 in period one
50 microgram PF-06273588 oralEXPERIMENTALSubjects will receive a single oral microdose of PF-06273588 in period two
Interventions
NameTypeDescription
PF-06273588DRUGIntravenous, 50 microgram, single dose
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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 (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical...

Countries:United Kingdom
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