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PF-04937319 / ketoconazole

Phase 1

Human Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Nov 16, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01468714A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy SubjectsPHASE1 COMPLETED 10Oct 1, 2011Oct 1, 2011Nov 16, 20111 United States
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Study Endpoints
Primary Endpoints
Cmax of PF-04937319
Day 1 & Day 6
Tmax of PF-04937319
Day 1 & Day 6
AUClast of PF-04937319
Day 1 & Day 6
(as data permits) AUCinf of PF-04937319
Day 1 & Day 6
(as data permits) t1/2 of PF-04937319
Day 1 & Day 6
Cmax of PF-04937319 M1 metabolite
Day 1 & Day 6
Tmax of PF-04937319 M1 metabolite
Day 1 & Day 6
AUClast of PF-04937319 M1 metabolite
Day 1 & Day 6
(as data permits) AUCinf of PF-04937319 M1 metabolite
Day 1 & Day 6
(as data permits) t1/2 of PF-04937319 M1 metabolite
Day 1 & Day 6
Secondary Endpoints
Urinary recovery of PF-04937319 M1 metabolite
Day 1
(as data permits) renal clearance (CLr) of PF-04937319 M1 metabolite
Day 1
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Interventions
NameTypeDescription
PF-04937319 / ketoconazoleDRUGSingle 20 mg dose of PF-04937319 on day 1, multiple dose of ketoconazole 200 mg twice daily from day 3 to 7, single 20 mg dose of PF-04937319 on day 6
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 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 pulse rate measurement, 12-lead ECG ...

Countries:United States
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