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Completed

NCT Number: NCT01234142

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

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

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Fargo, North Dakota, 58104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

varenicline free base patch

Drug

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

Placebo Patch

Drug

Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days

Primary outcomes

  1. 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

  2. Observed accumulation ratio (Rac)

    Time frame: Days 7 and 14

  3. Observed minimum plasma concentration (Cmin) in a given dosing interval, and peak: trough fluctuation (PTF)

    Time frame: Days 7 and 14

  4. Terminal half life (t1/2)

    Time frame: Day 14-Day 19

Secondary outcomes

  1. 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)

  2. VAS scores for nausea (using a Visual Analog Scale)

    Time frame: Days 1-19 (daily)

  3. 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)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 4, 2010
Registry last updated
Oct 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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