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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

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

NCT ID

NCT03259958

First Posted

August 21, 2017

Last Updated

July 31, 2018

Sponsor

Corium, Inc.

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

Data Monitoring Committee

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

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

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

IPD Sharing Plan Description

No Plans

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A Bioequivalence Study of Corplex™ Donepezil Transdermal Delivery System Compared to Aricept®

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