Recent Updates
Recently added Catalysts

PF-05212365

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 28, 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
UNCONTROLLED
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01253655To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy VolunteersPHASE1 COMPLETED 6 — — Nov 1, 2010Mar 1, 2011Apr 28, 20113 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Exposure response of 5-HT6 Receptor Occupancy (RO) of PF-05212365 in the striatum of healthy adult subjects
up to 4 days
Secondary Endpoints
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
continuous, up to 4 days
Change from baseline in orthostatic blood pressure
Baseline, -5 pre-dose, and 5, 51, and 72 hrs post-dose
Change from baseline in supine blood pressure
Baseline, -2.5, -1.5, -.5 pre-dose, and 2, 3, 4, 48, 49, 50 hrs post-dose
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-05212365EXPERIMENTAL -
Interventions
NameTypeDescription
PF-05212365DRUGSingle dose of up to 30 mg PF-05212365, delivered as 1 mg, 3 mg, and/or 5 mg on study day 1.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiat...

Countries:United States
Unlock Eligibility Criteria