NCT03438604

A Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil Transdermal Delivery System (TDS)

A Phase 1, 2-Way Crossover Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil 5 mg Transdermal Delivery System (TDS) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Corium, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

A study to assess the effect of heat application on the delivery profile of Corplex™ Donepezil Transdermal Delivery System (TDS)

Detailed description

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Donepezil TDS	Donepezil Hydrochloride Transdermal Delivery System

Timeline

• Start date: 2018-02-13
• Primary completion: 2018-06-19
• Completion: 2018-06-30
• First posted: 2018-02-19
• Last updated: 2018-09-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study