Clinical trial NCT03438604: A Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil Transdermal Delivery System (TDS)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Corium, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics, Cmax
timeFrame: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total
measure: Pharmacokinetics, AUC
timeFrame: Blood samples for the Donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Daily during 1 week treatment period and during the 5 week follow-on period
measure: Summary Listing of Skin Irritation Score of Donepezil TDS by post-removal time point
timeFrame: 0.5 hr, 24 hr, 48 hr, 72 hr after each TDS removal (3 days)
measure: Application Site Mean Adhesion Scores of Donepezil TDS
timeFrame: Daily during 1 week treatment period
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Celerion
name: Danielle Armas, MD
role: PRINCIPAL_INVESTIGATOR
References: