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PF-03882845

Phase 1

Healthy Volunteers | 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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01314898A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy VolunteersPHASE1 COMPLETED 12 — — Mar 1, 2011Jun 1, 2011Jul 6, 20111 United States
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Study Endpoints
Primary Endpoints
Twenty-four hour urinary Na/K ratio (AUC(0-24)).
0-24hr postdose per period
Secondary Endpoints
Area Under the Curve(AUClast) from the time of dosing to the last data point of PF-03882845.
0-24 hr post dose per period
Time of Maximum concentration(Tmax) of PF-03882845.
0-24 hr post dose per period
Maximum concentration (Cmax) of PF-03882845.
0-24 hr post dose per period
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TreatmentEXPERIMENTAL -
Interventions
NameTypeDescription
3 mg PF-03882845DRUG3 mg PF-03882845, single oral dose
10 mg PF-03882845DRUG10 mg PF-03882845, single oral dose
30 mg PF-03882845DRUG30 mg PF-03882845, single oral dose
100 mg PF-03882845DRUG100 mg PF-03882845, single oral dose
SpironolactoneDRUG100 mg spironolactone, single oral dose
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and/or female healthy volunteers, age 18 to 55 years. Females must be of non-childbearing potential. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * Subjects who are willing and able to comply with scheduled visits, treatment pl...

Countries:United States
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