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

A Phase 1, Investigator And Subject Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Cohort, Escalating Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of A Varenicline Transdermal Delivery System In Adult Smokers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01234142

Enrollment

Registered

2010-11-04

Start date

2010-11-30

Completion date

2011-03-31

Last updated

2011-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

varenicline transdermal percutaneous transcutaneous transdermal delivery system patch

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.

Interventions

DRUGvarenicline free base patch

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

DRUGplacebo patch

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026