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Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 15, 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
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01217918Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult SubjectsPHASE1 COMPLETED 30 — — Oct 1, 2010Feb 1, 2011Feb 15, 20112 United States
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Study Endpoints
Primary Endpoints
Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities.
Day 1 to Follow-up
Mean change from baseline in vital signs (blood pressure and heart rate) measurements
Baseline to Follow-up
Mean change from baseline in 12-lead ECG parameters
Baseline to Follow-up
Plasma PH-797804 Cmax, Cmin, Cavg(ss), Tmax, AUC(0-last), AUC(0-inf), AUC(0-tau), t1/2, CL/F, Vz/F, Rac, and Rac, Cmax
Days 1 and 10
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALPH-797804
Cohort 2EXPERIMENTALPH-797804
Cohotr 3EXPERIMENTALPH-797804
Interventions
NameTypeDescription
1 mgDRUG1 mg or placebo a material sparing tablet per day for 10 days
5 mgDRUG5 mg or placebo as material sparing tablet per day for 10 days
10 mgDRUG10 mg or placebo as a material sparing tablet per day for 10 days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy Volunteers * Japanese Exclusion Criteria: * Subjects with clinically significant skin lesions * Subjects with known tuberculosis infection

Countries:United States
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