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PF-04776548

Phase 1

Human Immunodeficiency Virus (HIV) | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Apr 2, 2010

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01045317A Study To Investigate The Clearance Of PF-04776548 From The Body Following A Very Low (Micro) Dose Of The Compound Using A Low Level Of Radiotracer To Help Quantify Expected Low Concentrations Of PF-04776548 In The BodyPHASE1 COMPLETED 10 — — Jan 1, 2010Feb 1, 2010Apr 2, 20101 United Kingdom
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Study Endpoints
Primary Endpoints
Pharmacokinetics: For IV dosing: Cmax, Tmax, AUClast, AUCinf, t½, CL, Vss. For oral dosing: Cmax, Tmax, Tlag, AUClast, AUCinf, t½, CL/F, Vz/F, F.
14 days
Secondary Endpoints
Safety and toleration: adverse events will also be reported.
14 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
intravenous or oral administrationEXPERIMENTAL -
Interventions
NameTypeDescription
PF-04776548DRUGsingle intravenous or oral administration of 0.1mg PF-04776548.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 65 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical l...

Countries:United Kingdom
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