NCT02968719

A Phase 1, Corplex™ Donepezil Transdermal System Compared to Oral Aricept®

Phase 1 Pharmacokinetic (PK) Study to Evaluate Once-weekly Corplex™ Donepezil Transdermal Delivery System Compared to Daily Oral Administration of Aricept® in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Corium, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Randomized, Open-Label, 3-Way Crossover, Pilot, Pharmacokinetic Study to Evaluate the Steady State Pharmacokinetics of a Once-Weekly Application of Corplex Donepezil Transdermal Delivery System (TDS) Compared to Daily Oral Administration of Aricept in Healthy Adult Subjects

Detailed description

Part A: 60 male and female subjects will be enrolled Subjects will receive 2 versions of once-weekly Corplex Donepezil TDS and QD oral Aricept; each administered for 35 days in 3 different treatment periods. For each treatment period; Subjects will receive a lead-in dose of approximately 5 mg donepezil/day for 7 days before commencing a dose of 10 mg donepezil/day for 28 days. Blood samples for donepezil PK and red blood cell (RBC) AChEI (as a potential pharmacodynamic \[PD\] marker) will be collected pre-dose through Week 8. Adhesion and skin irritation will be monitored throughout TDS Treatments. A washout period of at least 21 days between the last study drug administration (oral administration or removal of TDS, as appropriate) in each treatment period and the first application of TDS or oral drug administration, as appropriate, in the following treatment period. Safety will be monitored throughout the study by adverse event reporting, repeated clinical and laboratory evaluations Part B: Up to 47 subjects male and/or female will be enrolled This is an open-label, randomized, 2-way crossover sub-study. Eligible subjects will be randomized to 1 of 2 treatment sequences prior to the first TDS application. Subjects will receive 2 different once-weekly Corplex Donepezil TDS treatments (Treatments D and E), each administered for 1 week, in 2 different treatment periods (Treatment Period 1 and Treatment Period 2). In each treatment period, subjects will receive a target dose of 5 mg donepezil/day for 7 days. There will be a washout period of 35 days between removal of the first TDS in Treatment Period 1 and application of the second TDS in Treatment Period 2. Blood samples for donepezil PK will be collected pre-dose and through to Week 6 of each treatment period. Safety will be monitored throughout the sub-study by repeated clinical, skin irritation and laboratory evaluations.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Donepezil TDS Version A	Donepezil Hydrochloride Transdermal Delivery System (5mg and 10 mg Version B)
DRUG	Donepezil TDS Version B	Donepezil Hydrochloride Transdermal Delivery System (5 mg and 10 mg Version B)
DRUG	Aricept	Aricept (5 mg and 10 mg) Donepezil Hydrochloride
DRUG	Donepezil TDS Version D	Donepezil Hydrochloride Transdermal Delivery System (5 mg Version D)
DRUG	Donepezil TDS Version E	Donepezil Hydrochloride Transdermal Delivery System (5 mg Version E)

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-07-11
• Completion: 2017-07-11
• First posted: 2016-11-21
• Last updated: 2018-08-01

Locations

1 site across 1 country: United States