This study will evaluate the steady-state pharmacokinetics, safety and tolerability of a varenicline patch applied once daily to the skin for 14 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
45
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
varenicline transdermal delivery system (18.0 mg payload \[drug amount loaded in each patch\]) will be applied to the skin once daily for 14 days
Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days
Pfizer Investigational Site
Fargo, North Dakota, United States
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)
Time frame: Days 1, 7 and 14
Observed accumulation ratio (Rac)
Time frame: Days 7 and 14
Observed minimum plasma concentration (Cmin) in a given dosing interval, and peak: trough fluctuation (PTF)
Time frame: Days 7 and 14
Terminal half life (t1/2)
Time frame: Day 14-Day 19
Dermal rating scores (as measured by the Rating Scale for Assessment of Application Site Dermal-Erythema, Edema and Irritation)
Time frame: 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)
Time frame: Days 1-19 (daily)
Daily adhesion score (as measured by the Rating Scale for Adhesion)
Time frame: Days 1-14 (12 and 24 hpd);Days 1, 7 and 14 (1 and 6 hpd)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
varenicline transdermal delivery system (24.0 mg payload \[drug amount loaded in each patch\]) will be applied to the skin once daily for 14 days
Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days
2 varenicline transdermal delivery systems (combined to achieve a maximum drug payload of 36 mg) will be applied to the skin, side by side once daily, for 14 days
Matched placebo transdermal delivery systems will be applied to the skin, side by side, once daily for 14 days