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Varenicline Controlled Release

Phase 1

Pharmacokinetics | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 11, 2010

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00731562An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release FormulationPHASE1 COMPLETED 24 — — Jul 1, 2008Sep 1, 2008Jan 11, 20102 United States
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Study Endpoints
Primary Endpoints
Varenicline area under the curve (AUC) from time of study medication administration to last quantifiable plasma concentration (AUClast) and AUC from time of study medication administration to infinity (AUCinf).
5 days
Maximum plasma concentration of varenicline
1 day
Secondary Endpoints
Safety measures including adverse events
5 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Varenicline Controlled Release, FastedEXPERIMENTAL -
Varenicline Controlled Release, FedEXPERIMENTAL -
Interventions
NameTypeDescription
Varenicline Tartrate Controlled ReleaseDRUGA single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fasted conditions
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy male or female adult smokers * 18 to 55 years of age Exclusion Criteria: * Sensitivity to varenicline * Illegal drug use * Pregnant or nursing females

Countries:United States
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