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HCV-796

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Apr 14, 2008

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 Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00314054Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy AdultsPHASE1 COMPLETED 27May 1, 2006Oct 1, 2007Apr 14, 20083 United States
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Study Endpoints
Primary Endpoints
To assess PK in subjects with chronic hepatic impairment and in matched healthy adults
7 days
Secondary Endpoints
To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults
15 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALHCV-796 1000mg single dose
Interventions
NameTypeDescription
HCV-796DRUGHCV-796 1000mg single dose
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Men and women of non-childbearing potential. * Hepatic impairment subjects: Child-Pugh class A, B, or C according to the C-P classification based on history, physical examination, and laboratory test results. * Healthy volunteers: healthy as determined by the investigator. Ex...

Countries:United States
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Competitive Landscape -Hepatitis C 11 trials