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A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Patch Applied To The Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01013454
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : December 21, 2009
Information provided by:

Brief Summary:
This study will evaluate the single-dose pharmacokinetics, safety, and tolerability of a varenicline patch applied to the skin.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: varenicline free base patch Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : December 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Varenicline transdermal delivery system 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

Primary Outcome Measures :
  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 [ Time Frame: 8 days ]

Secondary Outcome Measures :
  1. Evaluation of adverse events (including skin irritation) [ Time Frame: 8 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy, Caucasian, male, adult light to regular smokers

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01013454

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Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01013454    
Other Study ID Numbers: A3051119
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: December 21, 2009
Last Verified: December 2009
Keywords provided by Pfizer:
varenicline percutaneous transcutaneous topical transdermal transdermal delivery system patch
Additional relevant MeSH terms:
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Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs