Status:
COMPLETED
A Study Evaluating the Absorption Of Varenicline Through The Skin Following Once Daily Application Of A Patch For 14 Days
Lead Sponsor:
Pfizer
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Healthy
- male or female
- adult cigarette smokers of any race
Exclusion
- 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).
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01234142
Start Date
November 1 2010
End Date
March 1 2011
Last Update
October 14 2011
Active Locations (1)
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1
Pfizer Investigational Site
Fargo, North Dakota, United States, 58104