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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00774605

Enrollment

Registered

2008-10-17

Start date

2008-12-31

Completion date

2008-12-31

Last updated

2009-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

percutaneous, transcutaneous, topical, varenicline, transdermal, transdermal delivery system, patch

Brief summary

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

Detailed description

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

Interventions

DRUGVarenicline 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

DRUGVarenicline 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy, adult, male smokers

Exclusion criteria

* significant medical illness

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Evaluation of adverse events (including skin irritation)	8 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026