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PF-06809247

Phase 1

Neuroinflammation | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 4, 2017

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03100136Test Re-Test Reliability of [11C]PF-06809247 as a Novel PET TacerPHASE1 COMPLETED 7 — — Nov 16, 2016Mar 10, 2017Apr 4, 20173 United States
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Study Endpoints
Primary Endpoints
binding kinetics of the novel tracer
Day 1, 0, 0:10, 0:20, 0:30, 0:40, 0:50, 1:00, 1:10, 1:20, 1:30, 1:45, 2:00, 2:15, 2:30, 2:45, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 15:00, 20:00, 25:00, 30:00, 45:00, 60:00, 75:00, 90:00, 105:00, 120:00, (min:sec)

Binding of \[11C\]PF-06809247 will be assessed by the evaluation of net uptake rate constant Ki (mL/min/g) in the various brain regions modeled, as data permit.

Secondary Endpoints
Change in Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Day 1
Test - Retest reliability
Day 1
Change in Physical examination
Day 1
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
[11C]PF-06809247EXPERIMENTALA dose intravenous injection of \[11C\]PF-06809247 followed by PET scanning.
Interventions
NameTypeDescription
[11C]PF-06809247DRUGPET Tracer
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Healthy male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: -Evidence or history of clinically significant hematological...

Countries:United States
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