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PF-868554

Phase 1

HEPATITIS C (HCV) | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Jan 3, 2014

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
CONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00651027Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554PHASE1 COMPLETED 24Feb 1, 2008Sep 1, 2008Jan 3, 20143 United States
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Study Endpoints
Primary Endpoints
PK parameters
8 day
Secondary Endpoints
safety and tolerability
8days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
CEXPERIMENTAL200 mg
Interventions
NameTypeDescription
PF-868554DRUG200 mg, Child-Pugh Class A
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Eligibility Criteria
Age Range18 Years — 62 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Male or females subjects of non-childbearing potential between the ages of 18 and 62 years of age, inclusive; * Body Mass Index (BMI) of approximately 18 to 35 kg/m2; and a total body weigh \>50 kg (110 lbs); Exclusion Criteria: * Subjects with Class C classification (Severe...

Countries:United States
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