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

Completed · Phase 1 · Has a placebo group

Conditions studied: Smoking Cessation

In brief

This study will evaluate the steady-state pharmacokinetics, safety and tolerability of a varenicline patch applied once daily to the skin for 14 days.

Key facts

Study ID

NCT01234142

Run by

Pfizer

People needed

45

Starts

2010-11-01

Expected to finish

2011-03-01

Last updated by the study team

2011-10-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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).

Where it is running

• Pfizer Investigational Site — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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