A Bioequivalence Study of Corplex™ Donepezil Transdermal Delivery System Compared to Aricept®
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Donepezil TDS
Aricept
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
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
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.
- Female subjects with a positive pregnancy test or lactating
- Positive urine drug or alcohol results
- 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
Any of the following drugs for 28 days prior to the first dose of study drug in Treatment Period 1 and throughout the study:
- significant inducers of cytochrome P450 (CYP) enzymes and/or P-glycoprotein;
- anti-inflammatory drugs or cyclooxygenase 2 (COX-2) analgesic;
- beta-blockers;
- anti-fungal medications;
- anti-histamines;
- cholinergics and anti-cholinergics;
- oral corticosteroids;
- Prolia;
- adjuvant analgesics
- Muscle relaxants, anti-Parkinsonian or neuroleptic medications prior to the first dose of study drug
- History or presence of excessive hairy skin on application sites as deemed by the Investigator to potentially interfere with drug absorption
- History or presence of significant skin damage, diffuse skin diseases, scars, tattoos on the application sites or other skin disturbances as deemed by the Investigator to potentially interfere with drug absorption or irritation assessments
- Use of donepezil hydrochloride or related drugs within 30 days prior to the first study drug administration
- Participation in another clinical study within 30 days prior to the first study drug administration
- Clinically significant depression symptoms or suicidal ideation or behavior as determined by the Investigator
Sites / Locations
- Celerion Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Donepezil TDS
Aricept
Arm Description
Corplex Donepezil TDS 5 mg/day followed by Donepezil TDS 10mg/day applied weekly for 5 consecutive weeks
Aricept 5 mg/day followed by Aricept 10 mg/day once daily for 5 consecutive weeks
Outcomes
Primary Outcome Measures
PK, AUC
To assess the plasma concentration (AUC) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride [HCl]).
PK, Cmax
To assess the maximum observed concentrations (Cmax) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride [HCl]).
Secondary Outcome Measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
General Safety (AE and SAE as reported by subject following guidance CTCAE v4.0)
PI assessment of local skin irritation response to TDS
To evaluate the safety and tolerability (including local skin irritation) of once-weekly Corplex Donepezil TDS. Dermal Response assessed using 8 point categorical scale. Other effects assessed using a 6 point scale.
PI assessment of TDS Adhesion
Adhesion data will be collected during each 7-day patch wear period throughout 5 week treatment period. Percent adherence will be assessed using 12 point categorical scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03259958
Brief Title
A Bioequivalence Study of Corplex™ Donepezil Transdermal Delivery System Compared to Aricept®
Official Title
A Study to Assess the Steady-State Bioequivalence of Once-Weekly Corplex™ 10mg Donepezil Transdermal Delivery System Compared to Daily Oral Administration of Aricept®
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
March 13, 2018 (Actual)
Study Completion Date
March 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corium, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to assess the steady-state bioequivalence of once-weekly Corplex™ Donepezil 10 mg Transdermal Delivery System (TDS) compared to daily administration of Aricept®
Detailed Description
Open label, randomized, 2-period, multiple-dose crossover study.
Approximately 86 healthy, adult male and female subjects will be enrolled.
Subjects will be randomized to 1 of 2 treatment sequences prior to the first study product treatment in treatment period 1.
For each treatment period; subjects will receive donepezil for 5 consecutive weeks. Blood samples for donepezil PK will be collected pre-dose through week 10.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Donepezil TDS
Arm Type
Experimental
Arm Description
Corplex Donepezil TDS 5 mg/day followed by Donepezil TDS 10mg/day applied weekly for 5 consecutive weeks
Arm Title
Aricept
Arm Type
Active Comparator
Arm Description
Aricept 5 mg/day followed by Aricept 10 mg/day once daily for 5 consecutive weeks
Intervention Type
Drug
Intervention Name(s)
Donepezil TDS
Intervention Description
Donepezil Hydrochloride Transdermal Delivery System
Intervention Type
Drug
Intervention Name(s)
Aricept
Intervention Description
Aricept Tablet
Primary Outcome Measure Information:
Title
PK, AUC
Description
To assess the plasma concentration (AUC) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride [HCl]).
Time Frame
Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total
Title
PK, Cmax
Description
To assess the maximum observed concentrations (Cmax) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride [HCl]).
Time Frame
Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
General Safety (AE and SAE as reported by subject following guidance CTCAE v4.0)
Time Frame
Daily during 5 week treatment period and during the 5 week follow-on period
Title
PI assessment of local skin irritation response to TDS
Description
To evaluate the safety and tolerability (including local skin irritation) of once-weekly Corplex Donepezil TDS. Dermal Response assessed using 8 point categorical scale. Other effects assessed using a 6 point scale.
Time Frame
0.5hr, 24hr, 48hr and 72hr after each TDS removal. (5 consecutive weeks)
Title
PI assessment of TDS Adhesion
Description
Adhesion data will be collected during each 7-day patch wear period throughout 5 week treatment period. Percent adherence will be assessed using 12 point categorical scale.
Time Frame
Daily during 5 week treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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.
Female subjects with a positive pregnancy test or lactating
Positive urine drug or alcohol results
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
Any of the following drugs for 28 days prior to the first dose of study drug in Treatment Period 1 and throughout the study:
significant inducers of cytochrome P450 (CYP) enzymes and/or P-glycoprotein;
anti-inflammatory drugs or cyclooxygenase 2 (COX-2) analgesic;
beta-blockers;
anti-fungal medications;
anti-histamines;
cholinergics and anti-cholinergics;
oral corticosteroids;
Prolia;
adjuvant analgesics
Muscle relaxants, anti-Parkinsonian or neuroleptic medications prior to the first dose of study drug
History or presence of excessive hairy skin on application sites as deemed by the Investigator to potentially interfere with drug absorption
History or presence of significant skin damage, diffuse skin diseases, scars, tattoos on the application sites or other skin disturbances as deemed by the Investigator to potentially interfere with drug absorption or irritation assessments
Use of donepezil hydrochloride or related drugs within 30 days prior to the first study drug administration
Participation in another clinical study within 30 days prior to the first study drug administration
Clinically significant depression symptoms or suicidal ideation or behavior as determined by the Investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Armas, MD
Organizational Affiliation
Celerion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Celerion Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No Plans
Learn more about this trial
A Bioequivalence Study of Corplex™ Donepezil Transdermal Delivery System Compared to Aricept®
We'll reach out to this number within 24 hrs