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PF-06743649

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 19, 2015

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02151617A Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649PHASE1 COMPLETED 40Jun 1, 2014Dec 1, 2014Jan 19, 20151 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
up to 14 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
up to 14 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
up to 14 days
Plasma Decay Half-Life (t1/2)
up to 14 days
Amount of drug recovered unchanged in urine during the dosing interval (Aetau)
up to 14 days
Percent of dose recovered unchanged in urine during the dosing interval(Aetau%)
up to 14 days
Renal clearance (CLr)
up to 14 days
Secondary Endpoints
Change from baseline in serum uric acid level
up to 14 days
Change from baseline in serum levels of xanthine and hypoxanthine
up to 14 days
Urinary uric acid levels
up to 14 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1-PF-06743649 or placeboEXPERIMENTALSubjects will be randomized to receive PF-06743649 or placebo as 2 single doses in periods 1 and 2 either in the fed or fasted state followed by once daily dosing for 14 days in period 3
Cohort 2-PF-06743649 or placeboEXPERIMENTAL -
Cohort 3-PF-06743649 or placeboEXPERIMENTAL -
Cohort 4-PF-06743649 or placeboEXPERIMENTAL -
Cohort 5-PF-06743649 or placeboEXPERIMENTAL -
Interventions
NameTypeDescription
PF-06743649DRUG40 mg tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
PlaceboDRUGPlacebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
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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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