A Study Evaluating the Absorption Of Varenicline Through The Skin Following Once Daily Application Of A Patch For 14 Days
Phase 1
Completed
- Conditions
- Smoking Cessation
- Interventions
- Drug: placebo patch
- Registration Number
- NCT01234142
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 varenicline free base patch - Cohort 2 varenicline free base patch - Cohort 2 placebo patch - Cohort 3 varenicline free base patch - Cohort 3 placebo patch - Cohort 4 varenicline free base patch - Cohort 4 placebo patch -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Fargo, North Dakota, United States