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Completed

NCT Number: NCT00774605

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

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

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy, adult, male smokers

Exclusion criteria

  • significant medical illness

Treatment and study plan

Varenicline free base solution

Drug

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

Drug

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

Primary outcomes

  1. 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 outcomes

  1. Evaluation of adverse events (including skin irritation)

    Time frame: 8 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 17, 2008
Registry last updated
Jan 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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