A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations

NCT ID: NCT03432195

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2018-06-28

Brief Summary

A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations

Detailed Description

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Donepezil TDS Back

Corplex Donepezil TDS 10 mg/day applied to the Back for 1 week (7 days)

Group Type: EXPERIMENTAL

Donepezil TDS

Intervention Type: DRUG

Donepezil Hydrochloride Transdermal Delivery System

Donepezil TDS Buttock

Corplex Donepezil TDS 10 mg/day applied to the Buttock for 1 week (7 days)

Group Type: EXPERIMENTAL

Donepezil TDS

Intervention Type: DRUG

Donepezil Hydrochloride Transdermal Delivery System

Donepezil TDS Leg

Corplex Donepezil TDS 10 mg/day applied to the Leg for 1 week (7 days)

Group Type: EXPERIMENTAL

Donepezil TDS

Intervention Type: DRUG

Donepezil Hydrochloride Transdermal Delivery System

Interventions

Donepezil TDS

Donepezil Hydrochloride Transdermal Delivery System

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy, adult, male or female
• Body mass index ≥ 18.0 and ≤ 32.0 kg/m2 at screening
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator
• Have a Fitzpatrick skin type of I, II or III or have skin colorimeter scores equivalent to the allowed Fitzpatrick skin type

Exclusion Criteria

• History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (including piperidine derivatives and other cholinesterase inhibitors)
• Has intolerance to venipuncture and/or inability to comply with the extensive blood sampling required for this study or does not have suitable veins in both arms
• Potential for occupational exposure to anticholinesterase agents
• Estimated creatinine clearance in non-elderly subjects <80 mL/min at screening and in elderly subjects (i.e., ≥55 years of age) <60 mL/min at screening
• Hemoglobin value of less than 11.5 g/dl for females, 13.0 g/dl for males at screening and first check-in
• Muscle relaxants, anti-Parkinsonian or neuroleptic medications prior to the first dose of study drug
• History or presence of significant skin damage or other skin disturbances as deemed by the Investigator to potentially interfere with patch procedures
• Use of donepezil hydrochloride or related drugs within 60 days prior to the first study drug administration
• Clinically significant depression symptoms or suicidal ideation or behavior as determined by the Investigator

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Corium, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Armas

Role: PRINCIPAL_INVESTIGATOR

Celerion

Locations

Celerion

Tempe, Arizona, United States

Countries

United States

Other Identifiers

P16012

Identifier Type: -

Identifier Source: org_study_id