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PF-06263726

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 17, 2014

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 Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01981681A Phase 1 Study To Evaluate Tolerability, Safety, And Pharmacokinetics Of Topical PF-06263276 In Healthy SubjectsPHASE1 COMPLETED 47 — — Nov 1, 2013Jun 1, 2014Jul 17, 20141 Belgium
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Study Endpoints
Primary Endpoints
Draize toxicity assessment score.
Day 8, Day 28

Changes from baseline on Draize toxicity assessment score.

Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) and physical examinations.
Day 23, Day 28
Changes from baseline in 12 lead electrocardiogram (ECG) parameters.
Day 23, Day 28

Quantitative changes in ECG intervals.

Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events.
Day 23, Day 28
Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry, fasting glucose, urinalysis.
Day 23, Day 28
Secondary Endpoints
Cohorts 3 and 4: Maximum Observed Plasma Concentration (Cmax)
Day 1, Day 14
Cohorts 3 and 4: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Day 1, Day 14
Cohorts 3 and 4: Area Under the Curve From Time Zero to 12 hours [AUC (0-12)]
Day 1, Day 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1 Experimental ArmEXPERIMENTAL -
Cohort 2 Experimental ArmEXPERIMENTAL -
Cohort 3 Experimental ArmEXPERIMENTAL -
Cohort 3 Placebo ArmPLACEBO_COMPARATOR -
Cohort 4 Experimental ArmEXPERIMENTAL -
Cohort 4 Placebo ArmPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-06263726DRUGSubjects will receive dose strength of 2% PF-06263276 (1.14 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back.
PlaceboDRUGSubjects will receive dose strength of 2% PF-06263276 (11.4 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects of non-childbearing potential 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 ...

Countries:Belgium
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