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Pharmacokinetics

Phase 1

Hepatitis C Virus | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Jul 8, 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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00861458Bioavailability Study Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed StatePHASE1 COMPLETED 14Apr 1, 2009Jun 1, 2009Jul 8, 20091 Belgium
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Study Endpoints
Primary Endpoints
AUC inf, Cmax
2 days
Secondary Endpoints
Adverse events
2 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-00868554EXPERIMENTAL -
Interventions
NameTypeDescription
PharmacokineticsDRUGSingle dose of 750 mg PF-00868554 as a solution and tablets.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteers. Exclusion Criteria: * Standard for healthy volunteers.

Countries:Belgium
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