A Phase 1 interventional study of Donepezil TDS in Alzheimer's Disease, sponsored by Corium, Inc.. Completed at 1 site in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-14.
Sponsored by Corium, Inc. · Phase 1, Interventional, and Treatment
A study to assess the effect of heat application on the delivery profile of Corplex™ Donepezil Transdermal Delivery System (TDS)
2-Way Crossover study
Approximately 24 healthy, adult male and female subjects will be enrolled.
Subjects will be randomized to 1 of 2 treatment sequences prior to the first TDS application in treatment period 1.
For each treatment period, subjects will have one 7-day TDS applied on their back. Depending on which sequence a subject is randomized to, the healthy subject will either be exposed to heat or not during the TDS wear time.
Blood samples for Donepezil PK will be collected pre-dose until the end of each treatment period.
Adhesion will be monitored throughout the TDS wear time, and skin irritation will be monitored after TDS removal.
Subjects who complete the 2-way crossover study may be eligible to participate in the optional Study Extension Period. In the Study Extension Period, subjects will have their skin surface temperature monitored under the patch and adjacent to the TDS.
Blood samples for Donepezil PK will not be collected, and adhesion will not be monitored for the Study Extension TDS wear period.
Safety will be monitored throughout the study by adverse event reporting and repeated clinical and laboratory evaluations.
Exclusion Criteria:
Corplex Donepezil TDS 5 mg/day with heat applied
Drug: Donepezil TDS
Corplex Donepezil TDS 5 mg/day with no heat applied
Drug: Donepezil TDS
Corplex Donepezil TDS 5 mg/day with heat. Two skin sensors will be placed underneath the TDS and adjacent to the TDS.
Drug: Donepezil TDS
Donepezil Hydrochloride Transdermal Delivery System
Pharmacokinetics, Cmax
Peak plasma concentration (Cmax) of once-weekly Donepezil TDS in the presence and absence of heat
Time frame: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total
Pharmacokinetics, AUC
Area under the curve (AUC) of once-weekly Donepezil TDS in the presence and absence of heat
Time frame: Blood samples for the Donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 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 and during the 5 week follow-on period
Summary Listing of Skin Irritation Score of Donepezil 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 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 the presence and absence of heat
Time frame: 0.5 hr, 24 hr, 48 hr, 72 hr after each TDS removal (3 days)
Application Site Mean Adhesion Scores of Donepezil TDS
Adhesion data will be collected during each 7-day patch wear period
Time frame: Daily during 1 week treatment period
Plan to share: No — No plans
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Corium, Inc.