A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Patch Applied To The Skin
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ClinicalTrials.gov Identifier: NCT01013454 |
Recruitment Status :
Completed
First Posted : November 13, 2009
Last Update Posted : December 21, 2009
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Sponsor:
Pfizer
Information provided by:
Pfizer
Tracking Information | ||||
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First Submitted Date ICMJE | November 11, 2009 | |||
First Posted Date ICMJE | November 13, 2009 | |||
Last Update Posted Date | December 21, 2009 | |||
Study Start Date ICMJE | December 2009 | |||
Actual Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 [ Time Frame: 8 days ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Evaluation of adverse events (including skin irritation) [ Time Frame: 8 days ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Patch Applied To The Skin | |||
Official Title ICMJE | 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 | |||
Brief Summary | This study will evaluate the single-dose pharmacokinetics, safety, and tolerability of a varenicline patch applied to the skin. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Smoking Cessation | |||
Intervention ICMJE | Drug: varenicline free base patch
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
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Study Arms ICMJE | Experimental: Varenicline transdermal delivery system
Intervention: Drug: varenicline free base patch
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
12 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2009 | |||
Actual Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01013454 | |||
Other Study ID Numbers ICMJE | A3051119 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | December 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |