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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01013454
First received: November 11, 2009
Last updated: December 18, 2009
Last verified: December 2009
  Purpose

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


Condition Intervention Phase
Smoking Cessation
Drug: varenicline free base patch
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of adverse events (including skin irritation) [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: December 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varenicline transdermal delivery system 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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013454

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01013454     History of Changes
Other Study ID Numbers: A3051119
Study First Received: November 11, 2009
Last Updated: December 18, 2009
Health Authority: FAMHP: Federal Agency for Medicines and Health Products

Keywords provided by Pfizer:
varenicline percutaneous transcutaneous topical transdermal transdermal delivery system patch

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014