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PF-05212377

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 16, 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-BlindCONTROLLEDBiomarker
Total Trials3
Total Enrollment76
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02005991A Study To Examine The Distribution Of PF-05212377 In The Brain Of Healthy Volunteer Subjects Using Positron Emission Tomography And A Radioactive Tracer Following Oral Administration Of One Dose Of PF-05212377PHASE1 COMPLETED 4 — — Nov 1, 2013Jan 1, 2014Apr 16, 20143 United States
NCT01258751This Study Will Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy VolunteersPHASE1 COMPLETED 12 — — Dec 1, 2010May 1, 2011Jul 6, 20113 United States
NCT01159496Multiple Ascending Dose Study To Assess Safety, Tolerability And Pharmacokinetics Of PF-05212377 (SAM-760)PHASE1 COMPLETED 60 — — Jul 1, 2010Dec 1, 2010Mar 10, 20111 France
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Study Endpoints
Primary Endpoints
5-HT2a receptor occupancy of PF-05212377 in the frontal cortex using PET
Days 1 and 2
Plasma PF-05212377 exposure associated with PF-05212377 5-HT2a receptor occupancy
Days 1 and 2
To assess the central 5-HT6 receptor occupancy (RO) in the striatum in relation to systemic exposure of PF-05212377 after single oral administration in healthy adult subjects.
up to 8 days
Adverse events (spontaneous and solicited).
0-24days
Change from baseline in vital signs.
0-24 days
Change from baseline in triplicate ECGs.
0-24 days
Clinical safety laboratory endpoints, including a complete blood count, reticulocytes and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive.
0-24 days
Physical examinations and neurological examinations
0-24 days
Secondary Endpoints
5-HT2a receptor occupancy of PF-05212377 in other cortical regions
Day 1 and 2
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
continuous, up to 8 days
Maximum concentration (Cmax) for PF-05212377 in plasma
up to 8 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-05212377 70 mgEXPERIMENTAL -
PF-05212377 20 mgEXPERIMENTAL -
PF-05212377 10 mgEXPERIMENTAL -
PF-05212377EXPERIMENTAL -
ActiveEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-05212377DRUGSingle, oral dose administration of 70 mg PF-0521377 using a capsule formulation.
PF-05212377 (SAM-760)DRUGOral capsule, once daily for 14 days 1.5 mg, 5 mg, 15 mg, 30 mg and 50 mg
PlaceboDRUGOral capsule, once daily for 14 days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Males and females must be at least 18 years of age and no older than 55 years of age with a Body Mass Index (BMI) must be between 17.5 and 30.5. * Subjects must sign a consent form and comply with all scheduled visits, treatment plan, lab tests and other study procedures. Exc...

Countries:United StatesFrance
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