A Study Evaluating the Absorption Of Varenicline Through The Skin Following Once Daily Application Of A Patch For 14 Days

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01234142
First received: August 14, 2009
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

This study will evaluate the steady-state pharmacokinetics, safety and tolerability of a varenicline patch applied once daily to the skin for 14 days.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1, Investigator And Subject Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Cohort, Escalating Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of A Varenicline Transdermal Delivery System In Adult Smokers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area under the plasma concentration-time curve (AUC24); observed maximum plasma concentration (Cmax) in a given dosing interval and time of maximum plasma concentration (Tmax) [ Time Frame: Days 1, 7 and 14 ] [ Designated as safety issue: No ]
  • Observed accumulation ratio (Rac) [ Time Frame: Days 7 and 14 ] [ Designated as safety issue: No ]
  • Observed minimum plasma concentration (Cmin) in a given dosing interval, and peak: trough fluctuation (PTF) [ Time Frame: Days 7 and 14 ] [ Designated as safety issue: No ]
  • Terminal half life (t1/2) [ Time Frame: Day 14-Day 19 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dermal rating scores (as measured by the Rating Scale for Assessment of Application Site Dermal-Erythema, Edema and Irritation) [ Time Frame: Days 1-14 (24 hpd); Days 1, 7-8 (1 and 12 hpd); Day 14 (1,6,12,24,48,72,96 and 120 hpd) ] [ Designated as safety issue: Yes ]
  • VAS scores for nausea (using a Visual Analog Scale) [ Time Frame: Days 1-19 (daily) ] [ Designated as safety issue: Yes ]
  • Daily adhesion score (as measured by the Rating Scale for Adhesion) [ Time Frame: Days 1-14 (12 and 24 hpd);Days 1, 7 and 14 (1 and 6 hpd) ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Drug: varenicline free base patch
varenicline transdermal delivery system (12.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days
Experimental: Cohort 2 Drug: varenicline free base patch
varenicline transdermal delivery system (18.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days
Drug: placebo patch
Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days
Experimental: Cohort 3 Drug: varenicline free base patch
varenicline transdermal delivery system (24.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days
Drug: placebo patch
Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days
Experimental: Cohort 4 Drug: varenicline free base patch
2 varenicline transdermal delivery systems (combined to achieve a maximum drug payload of 36 mg) will be applied to the skin, side by side once daily, for 14 days
Drug: placebo patch
Matched placebo transdermal delivery systems will be applied to the skin, side by side, once daily for 14 days

  Eligibility

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

Inclusion Criteria:

  • Healthy
  • male or female
  • adult cigarette smokers of any race

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).
  • Subjects with active suicidal ideation or suicidal behavior within 1 year prior to Screening as determined through the use of the C-SSRS (Columbia-Suicide Severity Rating Scale) or active ideation identified at Screening or Day 0.
  • 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: NCT01234142

Locations
United States, North Dakota
Pfizer Investigational Site
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01234142     History of Changes
Other Study ID Numbers: A3051142
Study First Received: August 14, 2009
Last Updated: October 13, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Smoking
Habits
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 July 26, 2014