Recent Updates
Recently added Catalysts

PF-03463275

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 20, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01159626Pharmacokinetics, Safety and Tolerability Study of PF-03463275 in Healthy Male Japanese and Western SubjectsPHASE1 COMPLETED 40 — — Jul 1, 2010Nov 1, 2010Apr 20, 20111 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Adverse events monitoring
Day 0 to Day 4 in each period of Cohort A, Day 0 to Day 10 in Cohort B
Vital signs, ECGs, clinical laboratory tests, clinical evaluations and examinations, suicidality assessment
Screening and Day 0 to Day 4 in each period of Cohort A, Screening and Day 0 to Day 10 in Cohort B
Serum (after single dose): Cmax, AUClast, AUCtau (Calculated only in Cohort B) and as data permit Tmax, AUCinf, t1/2
Day 1 to Day 4 in each period of Cohort A, Day 1 in Cohort B
Serum (after multiple dose): Ctrough, Cmax*, AUCtau* and as data permit Tmax*, t1/2* and Rac* (accumulation ratio) * Calculated only after the last administration.
Day 2 to Day 10 in Cohort B
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single doseEXPERIMENTAL -
Multiple doseEXPERIMENTAL -
Interventions
NameTypeDescription
PF-03463275DRUGOral single 20 mg dose as two 10mg controlled release tablets
PlaceboDRUGOral single dose as matching placebo
Unlock Study Design Details
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. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs). * Japanese subjects must have four Japanese grandparents who were born in Japan. Exclusion Criteria: * Subjects that are genot...

Countries:United States
Unlock Eligibility Criteria