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varenicline free base patch

Phase 1

Smoking Cessation | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 14, 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-BlindCONTROLLEDBiomarker
Total Trials3
Total Enrollment69
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01234142A Study Evaluating the Absorption Of Varenicline Through The Skin Following Once Daily Application Of A Patch For 14 DaysPHASE1 COMPLETED 45 — — Nov 1, 2010Mar 1, 2011Oct 14, 20111 United States
NCT01013454A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Patch Applied To The SkinPHASE1 COMPLETED 12 — — Dec 1, 2009Dec 1, 2009Dec 21, 20091 Belgium
NCT00774605A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Solution And A Varenicline Patch Applied To The SkinPHASE1 COMPLETED 12 — — Dec 1, 2008Dec 1, 2008Jan 26, 20091 United States
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Study Endpoints
Primary Endpoints
Area under the plasma concentration-time curve (AUC24); observed maximum plasma concentration (Cmax) in a given dosing interval and time of maximum plasma concentration (Tmax)
Days 1, 7 and 14
Observed accumulation ratio (Rac)
Days 7 and 14
Observed minimum plasma concentration (Cmin) in a given dosing interval, and peak: trough fluctuation (PTF)
Days 7 and 14
Terminal half life (t1/2)
Day 14-Day 19
Varenicline area under the curve from 0 to infinity (AUCinf) and varenicline area under the curve from 0 to the last quantifiable concentration (AUClast), as data permit
8 days
Varenicline area under the curve from 0 to the last quantifiable concentration (AUClast) and varenicline area under the curve from 0 to infinity (AUCinf)
8 days
Secondary Endpoints
Dermal rating scores (as measured by the Rating Scale for Assessment of Application Site Dermal-Erythema, Edema and Irritation)
Days 1-14 (24 hpd); Days 1, 7-8 (1 and 12 hpd); Day 14 (1,6,12,24,48,72,96 and 120 hpd)
VAS scores for nausea (using a Visual Analog Scale)
Days 1-19 (daily)
Daily adhesion score (as measured by the Rating Scale for Adhesion)
Days 1-14 (12 and 24 hpd);Days 1, 7 and 14 (1 and 6 hpd)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Cohort 3EXPERIMENTAL -
Cohort 4EXPERIMENTAL -
Varenicline transdermal delivery systemEXPERIMENTAL -
Varenicline free base solutionEXPERIMENTAL -
Interventions
NameTypeDescription
varenicline free base patchDRUGvarenicline transdermal delivery system (12.0 mg payload \[drug amount loaded in each patch\]) will be applied to the skin once daily for 14 days
placebo patchDRUGMatched placebo transdermal delivery system will be applied to the skin once daily for 14 days
Varenicline free base solutionDRUGA single application of a 4.8 mg varenicline solution will be applied to the upper back over a 24 hour period
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy * male or female * adult cigarette smokers of any race Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including d...

Countries:United StatesBelgium
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