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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00774605
First received: October 16, 2008
Last updated: January 22, 2009
Last verified: January 2009
  Purpose

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


Condition Intervention Phase
Smoking Cessation
Drug: Varenicline free base solution
Drug: Varenicline free base patch
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Varenicline area under the curve from 0 to the last quantifiable concentration (AUClast) and varenicline area under the curve from 0 to infinity (AUCinf) [ 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 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varenicline free base solution Drug: Varenicline 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
Experimental: Varenicline transdermal delivery system Drug: Varenicline 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy, adult, male smokers

Exclusion Criteria:

  • significant medical illness
  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: NCT00774605

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
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: NCT00774605     History of Changes
Other Study ID Numbers: A3051118
Study First Received: October 16, 2008
Last Updated: January 22, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014