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P3-Fast

Phase 1

Dermatitis, Atopic | Small molecule | Dermatology |Pfizer, Inc.|Last Updated: Jan 7, 2020

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04065633Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial FormulationPHASE1 COMPLETED 46 — — Jul 18, 2019Dec 14, 2019Jan 7, 20201 United States
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Study Endpoints
Primary Endpoints
Plasma PF-04965842 PK parameters
hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours post-dose

AUCinf

Secondary Endpoints
number of subjects with treatment-emergent adverse event
baseline until Period 4 study day 35
number of subjects with significant change from baseline in Supine Blood pressure, pulse rate and oral temperature
baseline until Period 4 study day 3
number of subjects with significant Changes from baseline for the ECG parameters QT interval, heart rate, QTc interval, PR
baseline until Period 4 study day 3
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Part A sequence 1EXPERIMENTAL -
Part A sequence 2EXPERIMENTAL -
Part B sequence 1EXPERIMENTAL -
Part B sequence 2EXPERIMENTAL -
Interventions
NameTypeDescription
P3-FastDRUG200 mg (2 × 100 mg) PF-04965842 Phase 3 tablet formulation under fasted conditions
Comm-FastDRUG200 mg PF-04965842 commercial tablet formulation under fasted conditions
Vari-FastDRUG200 mg PF-04965842 variant tablet formulation with slower dissolution under fasted conditions
Comm-FedDRUG200 mg PF-04965842 commercial tablet formulation under fed conditions
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb) Exclusion Criteria: * Any condition possibly affecting drug absorption (eg, gastrectomy). * History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis * Evidenc...

Countries:United States
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