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PF-04455242

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 7, 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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00956956A Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult SubjectsPHASE1 COMPLETED 36Sep 1, 2009Dec 1, 2009Jan 7, 20101 Singapore
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Study Endpoints
Primary Endpoints
Safety and tolerability of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects.
10 days
Plasma and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects.
10 days
Secondary Endpoints
Effect of multiple-doses of PF 04455242 on serum prolactin concentration.
10 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-04455242 treatmentEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-04455242DRUG3, 6, and 23 mg capsules administered orally Q6 hours for 7 days of dosing.
PlaceboDRUGPlacebo administered orally Q6 hours for 7 days of dosing.
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Eligibility Criteria
Age Range21 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects without childbearing potential between the ages of 21 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and puls...

Countries:Singapore
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