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PF-04449913, ketoconazole

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 10, 2013

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
CONTROLLED
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01749085Study To Determine The Effect Of Food And Strong CYP3A4 Enzyme Inhibitor On PF-04449913 Drug LevelsPHASE1 COMPLETED 14Dec 1, 2012Feb 1, 2013Apr 10, 20131 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
8 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
8 days
Secondary Endpoints
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
8 days
Apparent Oral Clearance (CL/F)
8 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
8 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Sequence 1EXPERIMENTAL -
Sequence 2EXPERIMENTAL -
Interventions
NameTypeDescription
PF-04449913, ketoconazoleDRUGSubjects receive a 200 mg oral dose of PF-04449913 under fasted conditions with washout, then single 200 mg oral dose of PF-04449913 under fed with washout and finally a single 200 mg dose 0f PF-04449913 following dosing to steady state with ketoconazole
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and 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 and...

Countries:United States
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