A Single Dose Study Investigating the Absorption and Elimination as Well as the Tolerability of Varenicline Transdermal Delivery System (e.g., a Patch) as Compared to Oral Varenicline in Adult Smokers.

Study Overview
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Brief Summary
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To evaluate the absorption and elimination of varenicline Formulation A transdermal delivery system [TDS (patch)] compared to varenicline immediate release tablet (CHANTIX®). To evaluate the adhesion of the varenicline Formulation A patch. To evaluate the safety and tolerability of a single application of the varenicline patch and a single oral dose of the varenicline immediate release tablet (CHANTIX®).

Official Title
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A Phase I, Open-Label, Randomized, Single Dose, Cross Over Study to Estimate the Relative Bioavailability of a Varenicline (CP-526,555) Transdermal Delivery System to the Chantix Immediate Release Tablet Formulation in Adult Smokers

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: varenicline tartrate
* Drug: varenicline free base


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy adult smokers Exclusion Criteria: Significant blood, kidney, lung, gastrointestinal, heart, liver, psychiatric, or neurologic disease Illegal drug usage

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chantix immediate release tablet formulation<br> | Drug: varenicline tartrate<br>* Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation<br>* Other names: varenicline, Chantix, Champix;|
| Experimental: Varenicline transdermal delivery system<br> | Drug: varenicline free base<br>* A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.<br>* Other names: varenicline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating Scale for Adhesive Residue (e.g., assesses how well the transdermal delivery system remains adhered to subject's skin) |  | 24 hours per Arm | 
| Rating Scale for Assessment of Application Site Dermal-Erythema, Edema, and Irritation (assesses skin irritation associated with varenicline transdermal delivery system) |  | 6 days per Arm | 
| Pharmacokinetic endpoints: plasma varenicline area under the curve (AUClast and AUCinf), maximum plasma concentration (Cmax), terminal half-life (t 1/2) and time of maximum plasma concentration (Tmax) |  | 6 days per Arm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Adhesidue/Cold Flow Assessment (assesses extent of adhesive residue which remains on the skin at application site as well as the adhesive flow beyond the application site border |  | 24 hours per Arm | 
| Evaluation of adverse events (including the visual analog scale for nausea), safety laboratory testing, electrocardiogram, vital signs |  | 6 days per Arm | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varenicline bioavailability transdermal smoking cessation