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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: October 16, 2008
Last updated: January 22, 2009
Last verified: January 2009
To evaluate the absorption, safety, and tolerability of a varenicline solution and a varenicline patch applied to the skin.

Condition Intervention Phase
Smoking Cessation
Drug: Varenicline free base solution
Drug: Varenicline free base patch
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Varenicline area under the curve from 0 to the last quantifiable concentration (AUClast) and varenicline area under the curve from 0 to infinity (AUCinf) [ Time Frame: 8 days ]

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

Enrollment: 12
Study Start Date: December 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varenicline free base solution Drug: Varenicline free base solution
A single application of a 4.8 mg varenicline solution will be applied to the upper back over a 24 hour period
Experimental: Varenicline transdermal delivery system Drug: Varenicline free base patch
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

Detailed Description:
Additional Study Purpose Details: Evaluation of the pharmacokinetic profile of a varenicline solution and a varenicline patch applied to the skin

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

Inclusion Criteria:

  • healthy, adult, male smokers

Exclusion Criteria:

  • significant medical illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00774605

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00774605     History of Changes
Other Study ID Numbers: A3051118
Study First Received: October 16, 2008
Last Updated: January 22, 2009

Keywords provided by Pfizer:
percutaneous, transcutaneous, topical, varenicline, transdermal, transdermal delivery system, patch

Additional relevant MeSH terms:
Pharmaceutical Solutions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on April 28, 2017