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NCT01013454 Clinical Trial

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

Smoking Cessation Clinical Trial

Official title:
A Phase 1, Open-Label, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Delivery System Applied To The Skin Of Adult Smokers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01013454
Other study ID # A3051119
Secondary ID
Status Completed
Phase Phase 1
First received November 11, 2009
Last updated December 18, 2009
Start date December 2009
Est. completion date December 2009

Study information
Verified date December 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority FAMHP: Federal Agency for Medicines and Health Products
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• varenicline free base patch
varenicline transdermal delivery system (6.0 mg payload [drug amount loaded in each patch]) will be applied to the upper back over a single 24 hour period

Locations
Country Name City State
Belgium Pfizer Investigational Site Bruxelles

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Evaluation of adverse events (including skin irritation) 8 days Yes
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