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NCT00774605 Clinical Trial

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

Smoking Cessation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00774605
Other study ID # A3051118
Secondary ID
Status Completed
Phase Phase 1
First received October 16, 2008
Last updated January 22, 2009
Start date December 2008
Est. completion date December 2008

Study information
Verified date January 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To evaluate the absorption, safety, and tolerability of a varenicline solution and a varenicline patch applied to the skin.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- healthy, adult, male smokers

Exclusion Criteria:

- significant medical illness

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
United States Pfizer Investigational Site New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Varenicline area under the curve from 0 to the last quantifiable concentration (AUClast) and varenicline area under the curve from 0 to infinity (AUCinf) 8 days No
Secondary Evaluation of adverse events (including skin irritation) 8 days Yes
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