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Recently added Catalysts

-PF-00868554

Phase 1

HCV | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 9, 2009

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
NCT00823745Radiolabel ADME (Absorption, Distribution, Metabolism, and Excretion) Study Of [14C] PF-00868554 In Healthy Adult Male SubjectsPHASE1 COMPLETED 7 — — Jan 1, 2009Feb 1, 2009Mar 9, 20091 United States
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Study Endpoints
Primary Endpoints
The amount of radioactivity recovered in urine and feces, as a percent of the dose.
7 weeks
The amount of PF-00868554, expressed as a percent of total radioactivity, in plasma, urine, and feces.
7 weeks
Identification and determination of relative abundance of the metabolites of PF-00868554 in plasma, urine, and feces.
7 weeks
PK parameters: AUClast, AUCinf, maximum concentration (Cmax), time of maximum concentration (Tmax), and half-life (t1/2) to describe the single dose PK of a) total radioactivity in blood; b) total radioactivity in plasma; c) PF-00868554 in plasma.
7 weeks
Secondary Endpoints
Safety endpoints including adverse events, clinical laboratory tests, vital signs and ECGs.
7 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL\[14C\]-PF-00868554
Interventions
NameTypeDescription
[14C]-PF-00868554DRUGsolution, single dose
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male, healthy volunteers. Exclusion Criteria: * Females.

Countries:United States
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