A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations
Randomized, open-label, 3-way crossover study Up to 66 healthy, adult male and female subjects will be enrolled. All subjects will receive Corplex Donepezil TDS patches applied to 3 different locations on each subject (back, buttock, and leg) during 3 different, consecutive treatment periods. For each subject, the location of product administration during each treatment period will be randomized. During each treatment period, all subjects will receive a once-weekly 10 mg TDS, target dose 10 mg donepezil/day, applied for 7 days (1 week) on either the back, buttock, or leg in accordance with the randomized treatment location for that treatment period. Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period. The PK sample collection time points are as follows: Week 1: Pre-TDS application prior to 0 hour and post-TDS application at 2, 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 hours. Week 2: Pre-Week 1 TDS removal at 168 hours, and post-TDS removal at up to 528 hours Adhesion and skin irritation will be monitored throughout TDS treatments. Safety will be monitored throughout the study by adverse event reporting, repeated clinical and laboratory evaluations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Donepezil Hydrochloride Transdermal Delivery System
Celerion
Tempe, Arizona, United States
Pharmacokinetics, AUC
Area under the plasma concentration versus time curve (AUC) of once-weekly Corplex Donepezil TDS applied to different body locations.
Time frame: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total
Pharmacokinetics, CMAX
Peak Plasma Concentration (Cmax) of once-weekly Corplex Donepezil TDS applied to different body locations.
Time frame: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
General Safety (adverse events and serious adverse events as reported by subject following guidance CTCAE v4.0)
Time frame: Daily during 1 week treatment period throughout the 5 week period
Summary Listing of Skin Irritation Score of Donepezil Corplex TDS by post-removal time point
Skin irritation score is determined by the sum of Dermal Response score (8-point categorical scale; where 0=no evidence of irritation to 7=strong reaction) using numeric values) and the Other Effects score (6-point categorical scale where 0=none observed to H=scabs/erosion using alphabet letters equivalent to numeric values) and summarized by application site (back, buttock and leg)
Time frame: 0.5hr, 24hr, 48hr and 72hr after each TDS removal. (3 days)
Application Site Mean Adhesion Scores of Donepezil Corplex TDS
Adhesion score is collected using a 12-point categorical scale, where 0=100% adhered to 11=detached
Time frame: Daily during 1 week treatment period
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