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

Smoking Cessation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234142
• Other study ID #: A3051142
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2009
• Last updated: October 13, 2011
• Start date: November 2010
• Est. completion date: March 2011

Study information

• Verified date: October 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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
• 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
• placebo patch
Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days
• 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
• placebo patch
Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days
• 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
• placebo patch
Matched placebo transdermal delivery systems will be applied to the skin, side by side, once daily for 14 days

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Days 1, 7 and 14	No
Primary	Observed accumulation ratio (Rac)		Days 7 and 14	No
Primary	Observed minimum plasma concentration (Cmin) in a given dosing interval, and peak: trough fluctuation (PTF)		Days 7 and 14	No
Primary	Terminal half life (t1/2)		Day 14-Day 19	No
Secondary	Dermal rating scores (as measured by the Rating Scale for Assessment of Application Site Dermal-Erythema, Edema and Irritation)		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)	Yes
Secondary	VAS scores for nausea (using a Visual Analog Scale)		Days 1-19 (daily)	Yes
Secondary	Daily adhesion score (as measured by the Rating Scale for Adhesion)		Days 1-14 (12 and 24 hpd);Days 1, 7 and 14 (1 and 6 hpd)	No

External Links

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