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

• ClinicalTrials.gov Identifier: NCT01013454
• Recruitment Status: Completed
• First Posted: November 13, 2009
• Last Update Posted: December 21, 2009
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: November 11, 2009
• First Posted Date: November 13, 2009
• Last Update Posted Date: December 21, 2009
• Study Start Date: December 2009
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 11, 2009): 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 [ Time Frame: 8 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 11, 2009): Evaluation of adverse events (including skin irritation) [ Time Frame: 8 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Patch Applied To The Skin
• 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
• Brief Summary: This study will evaluate the single-dose pharmacokinetics, safety, and tolerability of a varenicline patch applied to the skin.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Smoking Cessation

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

Study Arms

Experimental: Varenicline transdermal delivery system

Intervention: Drug: varenicline free base patch

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 11, 2009): 12
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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).

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT01013454
• Other Study ID Numbers: A3051119
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: December 2009