A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Solution And A Varenicline Patch Applied To The Skin
A Phase 1, Open-Label, Nonrandomized, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Solution And A Varenicline Transdermal Delivery System Applied To The Skin Of Adult Smokers
1 other identifier
interventional
12
1 country
1
Brief Summary
To evaluate the absorption, safety, and tolerability of a varenicline solution and a varenicline patch applied to the skin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2008
CompletedFirst Posted
Study publicly available on registry
October 17, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 26, 2009
January 1, 2009
Same day
October 16, 2008
January 22, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Evaluation of adverse events (including skin irritation)
8 days
Study Arms (2)
Varenicline free base solution
EXPERIMENTALVarenicline transdermal delivery system
EXPERIMENTALInterventions
A single application of a 4.8 mg varenicline solution will be applied to the upper back over a 24 hour period
A single application of a nominal 1.2 mg dose of a varenicline transdermal delivery system (5 cm2 patch, 4.8 mg drug payload) will be applied to the upper back over a 24 hour period
Eligibility Criteria
You may qualify if:
- healthy, adult, male smokers
You may not qualify if:
- significant medical illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 16, 2008
First Posted
October 17, 2008
Study Start
December 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
January 26, 2009
Record last verified: 2009-01