A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Patch Applied To The Skin
A Phase 1, Open-Label, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Delivery System Applied To The Skin Of Adult Smokers
1 other identifier
interventional
12
1 country
1
Brief Summary
This study will evaluate the single-dose pharmacokinetics, safety, and tolerability of 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 2009
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
November 11, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedDecember 21, 2009
December 1, 2009
Same day
November 11, 2009
December 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Evaluation of adverse events (including skin irritation)
8 days
Study Arms (1)
Varenicline transdermal delivery system
EXPERIMENTALInterventions
varenicline transdermal delivery system (6.0 mg payload \[drug amount loaded in each patch\]) will be applied to the upper back over a single 24 hour period
Eligibility Criteria
You may qualify if:
- Healthy, Caucasian, male, adult light to regular smokers
You may not qualify if:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption through the skin (eg, psoriasis).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, 1070, Belgium
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
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 11, 2009
First Posted
November 13, 2009
Study Start
December 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
December 21, 2009
Record last verified: 2009-12