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

NCT01234142 | Completed Phase 1

• 1 other identifier: A3051142
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation

Keywords

varenicline transdermal percutaneous transcutaneous transdermal delivery system patch

Outcome Measures

Primary Outcomes (4)

• 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

• Observed accumulation ratio (Rac)

  Days 7 and 14

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

  Days 7 and 14

• Terminal half life (t1/2)

  Day 14-Day 19

Secondary Outcomes (3)

• 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)

• VAS scores for nausea (using a Visual Analog Scale)

  Days 1-19 (daily)

• 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)

Study Arms (4)

Cohort 1

EXPERIMENTAL

Drug: varenicline free base patch

Cohort 2

EXPERIMENTAL

Drug: varenicline free base patch; Drug: placebo patch

Cohort 3

EXPERIMENTAL

Drug: varenicline free base patch; Drug: placebo patch

Cohort 4

EXPERIMENTAL

Drug: varenicline free base patch; Drug: placebo patch

Interventions

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

Cohort 1

placebo patch DRUG

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

Cohort 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Fargo, North Dakota, 58104, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: November 4, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 14, 2011

Record last verified: 2011-10

Locations

US (1)