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

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

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Donepezil 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy, adult, male or female ≥ 30 years of age

Exclusion Criteria:

• History of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the subject by participation in the study
• History or presence of alcoholism or drug abuse within the past 2 years prior to the first study product treatment
• History or presence of hypersensitivity or idiosyncratic reaction to the study products or related compounds
• History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs
• History or presence of excessive sweating
• History or presence of hairy skin on application sites
• History or presence of significant skin damage or disease at application sites
• Any medical or surgical procedure or trauma within 28 days prior to the first study product treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Donepezil TDS with Heat Applied; Corplex Donepezil TDS 5 mg/day with heat applied	Drug: Donepezil TDS; Donepezil Hydrochloride Transdermal Delivery System
Other: Donepezil TDS without Heat; Corplex Donepezil TDS 5 mg/day with no heat applied	Drug: Donepezil TDS; Donepezil Hydrochloride Transdermal Delivery System
Other: Donepezil TDS Extension Study with Heat; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics, Cmax	Peak plasma concentration (Cmax) of once-weekly Donepezil TDS in the presence and absence of heat	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	Blood samples for the Donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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	Daily during 1 week treatment period

Collaborators and Investigators

• Sponsor: Corium, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Actual): June 19, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: P-16039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plans

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No