- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03432195
A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations
A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85283
- Celerion
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Key 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Donepezil TDS Back
Corplex Donepezil TDS 10 mg/day applied to the Back for 1 week (7 days)
|
Donepezil Hydrochloride Transdermal Delivery System
|
EXPERIMENTAL: Donepezil TDS Buttock
Corplex Donepezil TDS 10 mg/day applied to the Buttock for 1 week (7 days)
|
Donepezil Hydrochloride Transdermal Delivery System
|
EXPERIMENTAL: Donepezil TDS Leg
Corplex Donepezil TDS 10 mg/day applied to the Leg for 1 week (7 days)
|
Donepezil Hydrochloride Transdermal Delivery System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics, AUC
Time Frame: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total
|
Area under the plasma concentration versus time curve (AUC) of once-weekly Corplex Donepezil TDS applied to different body locations.
|
Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total
|
Pharmacokinetics, CMAX
Time Frame: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total
|
Peak Plasma Concentration (Cmax) of once-weekly Corplex Donepezil TDS applied to different body locations.
|
Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 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
Time Frame: Daily during 1 week treatment period throughout the 5 week period
|
General Safety (adverse events and serious adverse events as reported by subject following guidance CTCAE v4.0)
|
Daily during 1 week treatment period throughout the 5 week period
|
Summary Listing of Skin Irritation Score of Donepezil Corplex TDS by post-removal time point
Time Frame: 0.5hr, 24hr, 48hr and 72hr after each TDS removal. (3 days)
|
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 the 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 application site (back, buttock and leg)
|
0.5hr, 24hr, 48hr and 72hr after each TDS removal. (3 days)
|
Application Site Mean Adhesion Scores of Donepezil Corplex TDS
Time Frame: Daily during 1 week treatment period
|
Adhesion score is collected using a 12-point categorical scale, where 0=100% adhered to 11=detached
|
Daily during 1 week treatment period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Danielle Armas, Celerion
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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
- P16012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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