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.

• ClinicalTrials.gov Identifier: NCT00661765
• Recruitment Status: Completed
• First Posted: April 18, 2008
• Last Update Posted: April 23, 2009
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: April 14, 2008
• First Posted Date: April 18, 2008
• Last Update Posted Date: April 23, 2009
• Study Start Date: April 2008
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2008)

• Rating Scale for Adhesive Residue (e.g., assesses how well the transdermal delivery system remains adhered to subject's skin) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 6 days per Arm ]

Original Primary Outcome Measures (submitted: April 14, 2008)

• 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) [ Time Frame: 6 days per Arm ]
• Rating Scale for Adhesion (e.g., assesses how well the transdermal delivery system remains adhered to subject's skin) [ Time Frame: 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) [ Time Frame: 6 days per Arm ]

Current Secondary Outcome Measures (submitted: April 14, 2008)

• 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 [ Time Frame: 24 hours per Arm ]
• Evaluation of adverse events (including the visual analog scale for nausea), safety laboratory testing, electrocardiogram, vital signs [ Time Frame: 6 days per Arm ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• Official Title: 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

Brief Summary

1. To evaluate the absorption and elimination of varenicline Formulation A transdermal delivery system [TDS (patch)] compared to varenicline immediate release tablet (CHANTIX®).
2. To evaluate the adhesion of the varenicline Formulation A patch.
3. 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®).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label)
• Condition: Smoking Cessation

Intervention

• Drug: varenicline tartrate
  Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation
  Other Name: varenicline, Chantix, Champix
• Drug: varenicline free base
  A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.
  Other Name: varenicline

Study Arms

• Active Comparator: Chantix immediate release tablet formulation
  Intervention: Drug: varenicline tartrate
• Experimental: Varenicline transdermal delivery system
  Intervention: Drug: varenicline free base

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 14, 2008): 18
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2008
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• healthy adult smokers

Exclusion Criteria:

• Significant blood, kidney, lung, gastrointestinal, heart, liver, psychiatric, or neurologic disease
• Illegal drug usage

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00661765
• Other Study ID Numbers: A3051071
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: April 2009