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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438604
• Other study ID #: P-16039
• Status: Completed
• Phase: Phase 1
• Start date: February 13, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: September 2018
• Source: Corium International Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2018
• Est. primary completion date: June 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Donepezil TDS
Donepezil Hydrochloride Transdermal Delivery System

Locations

Country	Name	City	State
United States	Celerion	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Corium International Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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)
Secondary	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