A Study Evaluating the Absorption Of Varenicline Through The Skin Following Once Daily Application Of A Patch For 14 Days
NCT ID: NCT01234142
Last Updated: 2011-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2010-11-30
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Cohort 1
varenicline free base patch
varenicline transdermal delivery system (12.0 mg payload \[drug amount loaded in each patch\]) will be applied to the skin once daily for 14 days
Cohort 2
varenicline free base patch
varenicline transdermal delivery system (18.0 mg payload \[drug amount loaded in each patch\]) will be applied to the skin once daily for 14 days
placebo patch
Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days
Cohort 3
varenicline free base patch
varenicline transdermal delivery system (24.0 mg payload \[drug amount loaded in each patch\]) will be applied to the skin once daily for 14 days
placebo patch
Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days
Cohort 4
varenicline free base patch
2 varenicline transdermal delivery systems (combined to achieve a maximum drug payload of 36 mg) will be applied to the skin, side by side once daily, for 14 days
placebo patch
Matched placebo transdermal delivery systems will be applied to the skin, side by side, once daily for 14 days
Interventions
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varenicline free base patch
varenicline transdermal delivery system (12.0 mg payload \[drug amount loaded in each patch\]) will be applied to the skin once daily for 14 days
varenicline free base patch
varenicline transdermal delivery system (18.0 mg payload \[drug amount loaded in each patch\]) will be applied to the skin once daily for 14 days
placebo patch
Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days
varenicline free base patch
varenicline transdermal delivery system (24.0 mg payload \[drug amount loaded in each patch\]) will be applied to the skin once daily for 14 days
placebo patch
Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days
varenicline free base patch
2 varenicline transdermal delivery systems (combined to achieve a maximum drug payload of 36 mg) will be applied to the skin, side by side once daily, for 14 days
placebo patch
Matched placebo transdermal delivery systems will be applied to the skin, side by side, once daily for 14 days
Eligibility Criteria
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Inclusion Criteria
* male or female
* adult cigarette smokers of any race
Exclusion Criteria
* Subjects with active suicidal ideation or suicidal behavior within 1 year prior to Screening as determined through the use of the C-SSRS (Columbia-Suicide Severity Rating Scale) or active ideation identified at Screening or Day 0.
* Any condition possibly affecting drug absorption through the skin (eg, psoriasis).
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Fargo, North Dakota, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3051142
Identifier Type: -
Identifier Source: org_study_id