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PF-04878691

Phase 1

Hepatitis C Virus | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Dec 1, 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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00810758Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691PHASE1 COMPLETED 24Jan 1, 2009Nov 1, 2009Dec 1, 20091 United States
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Study Endpoints
Primary Endpoints
To assess the safety and toleration of multiple ascending oral doses of PF-04878691
3 weeks
Secondary Endpoints
To assess the pharmacokinetics and pharmacodynamics with regards to specific biomarkers of immune stimulation of PF-04878691
3 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-04878691EXPERIMENTAL -
Interventions
NameTypeDescription
PF-04878691 3mgDRUGOral solution, 3mg, twice weekly, 2 weeks
PF-04878691 6mgDRUGOral solution, 6mg, twice weekly, 2 weeks
PF-04878691 9mgDRUGOral solution, 9mg, twice weekly, 2 weeks
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18-55, inclusive. * Body Mass Index (BMI) of 18-30 kg/m2; total body weight \>50kg (110lbs). Exclusion Criteria: * Pregnant or nursing females. * Females of child-bearing potential. * Evidence of history of clinically s...

Countries:United States
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