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Formulation 1

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 6, 2011

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01351129Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy VolunteersPHASE1 COMPLETED 12May 1, 2011Jun 1, 2011Jul 6, 20111 Singapore
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Study Endpoints
Primary Endpoints
Area under the plasma concentration versus time profile (AUC)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
Secondary Endpoints
Max observed plasma concentration (Cmax)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
Time of Cmax (Tmax)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
Concentration at 24 hours postdose (C24hr)
24 hrs postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Formulation 1EXPERIMENTAL -
Formulation 2EXPERIMENTAL -
Formulation 3EXPERIMENTAL -
Interventions
NameTypeDescription
Formulation 1DRUG150-mg immediate release tablet (single dose)
Formulation 2DRUG150-mg modified release capsule, short duration (single dose)
Formulation 3DRUG150-mg modified release capsule, long duration (single dose)
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Eligibility Criteria
Age Range21 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * An informed consent document signed and dated by the subject. Exclusion...

Countries:Singapore
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