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

Phase 1

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: varenicline free base patch

• Registration Number: NCT01013454
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-11
• Study First Submitted QC: 2009-11-11
• Study First Posted: 2009-11-13
• Status Verified: 2009-12
• Study Start: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2009-12-18
• Last Update Posted: 2009-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Varenicline transdermal delivery system	varenicline free base patch	-

Primary Outcome Measures

Name	Time	Method
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	8 days

Secondary Outcome Measures

Name	Time	Method
Evaluation of adverse events (including skin irritation)	8 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium