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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Smoking Cessation

Treatments: Drug: placebo patch; Drug: varenicline free base patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01234142

A3051142

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

45 participants in 4 patient groups

Cohort 1

Experimental group

Treatment:

Drug: varenicline free base patch

Drug: varenicline free base patch

Drug: varenicline free base patch

Drug: varenicline free base patch

Cohort 2

Experimental group

Treatment:

Drug: placebo patch

Drug: placebo patch

Drug: varenicline free base patch

Drug: placebo patch

Drug: varenicline free base patch

Drug: varenicline free base patch

Drug: varenicline free base patch

Cohort 3

Experimental group

Treatment:

Drug: placebo patch

Drug: placebo patch

Drug: varenicline free base patch

Drug: placebo patch

Drug: varenicline free base patch

Drug: varenicline free base patch

Drug: varenicline free base patch

Cohort 4

Experimental group

Treatment:

Drug: placebo patch

Drug: placebo patch

Drug: varenicline free base patch

Drug: placebo patch

Drug: varenicline free base patch

Drug: varenicline free base patch

Drug: varenicline free base patch