Back to results

A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Donepezil TDS

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
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

Sites / Locations

Celerion

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Donepezil TDS Back

Donepezil TDS Buttock

Donepezil TDS Leg

Arm Description

Corplex Donepezil TDS 10 mg/day applied to the Back for 1 week (7 days)

Corplex Donepezil TDS 10 mg/day applied to the Buttock for 1 week (7 days)

Corplex Donepezil TDS 10 mg/day applied to the Leg for 1 week (7 days)

Outcomes

Primary Outcome Measures

Pharmacokinetics, AUC

Area under the plasma concentration versus time curve (AUC) of once-weekly Corplex Donepezil TDS applied to different body locations.

Pharmacokinetics, CMAX

Peak Plasma Concentration (Cmax) of once-weekly Corplex Donepezil TDS applied to different body locations.

Secondary Outcome Measures

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)

Summary Listing of Skin Irritation Score of Donepezil Corplex 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 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)

Application Site Mean Adhesion Scores of Donepezil Corplex TDS

Adhesion score is collected using a 12-point categorical scale, where 0=100% adhered to 11=detached

Full Information

NCT ID

NCT03432195

First Posted

January 31, 2018

Last Updated

August 6, 2018

Sponsor

Corium, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03432195

Brief Title

A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations

Official Title

A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

January 31, 2018 (Actual)

Primary Completion Date

June 28, 2018 (Actual)

Study Completion Date

June 28, 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 Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations

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.

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

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Donepezil TDS Back

Arm Type

Experimental

Arm Description

Corplex Donepezil TDS 10 mg/day applied to the Back for 1 week (7 days)

Arm Title

Donepezil TDS Buttock

Arm Type

Experimental

Arm Description

Corplex Donepezil TDS 10 mg/day applied to the Buttock for 1 week (7 days)

Arm Title

Donepezil TDS Leg

Arm Type

Experimental

Arm Description

Corplex Donepezil TDS 10 mg/day applied to the Leg for 1 week (7 days)

Intervention Type

Drug

Intervention Name(s)

Donepezil TDS

Intervention Description

Donepezil Hydrochloride Transdermal Delivery System

Primary Outcome Measure Information:

Title

Pharmacokinetics, AUC

Description

Area under the plasma concentration versus time curve (AUC) of once-weekly Corplex Donepezil TDS applied to different body locations.

Time Frame

Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total

Title

Pharmacokinetics, CMAX

Description

Peak Plasma Concentration (Cmax) of once-weekly Corplex Donepezil TDS applied to different body locations.

Time Frame

Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total

Secondary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Description

General Safety (adverse events and serious adverse events as reported by subject following guidance CTCAE v4.0)

Time Frame

Daily during 1 week treatment period throughout the 5 week period

Title

Summary Listing of Skin Irritation Score of Donepezil Corplex TDS by post-removal time point

Description

Time Frame

0.5hr, 24hr, 48hr and 72hr after each TDS removal. (3 days)

Title

Application Site Mean Adhesion Scores of Donepezil Corplex TDS

Description

Adhesion score is collected using a 12-point categorical scale, where 0=100% adhered to 11=detached

Time Frame

Daily during 1 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Danielle Armas

Organizational Affiliation

Celerion

Official's Role

Principal Investigator

Facility Information:

Facility Name

Celerion

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85283

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

no plans

Learn more about this trial

A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations

We'll reach out to this number within 24 hrs