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

August 6, 2018 updated by: Corium, Inc.

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

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

66

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Celerion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
Drug: Donepezil TDS
Donepezil Hydrochloride Transdermal Delivery System
EXPERIMENTAL: Donepezil TDS Buttock
Corplex Donepezil TDS 10 mg/day applied to the Buttock for 1 week (7 days)
Drug: Donepezil TDS
Donepezil Hydrochloride Transdermal Delivery System
EXPERIMENTAL: Donepezil TDS Leg
Corplex Donepezil TDS 10 mg/day applied to the Leg for 1 week (7 days)
Drug: Donepezil TDS
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

This is where you will find people and organizations involved with this study.

Sponsor

Corium, Inc.

Investigators

  • Principal Investigator: Danielle Armas, Celerion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 31, 2018

Primary Completion (ACTUAL)

June 28, 2018

Study Completion (ACTUAL)

June 28, 2018

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

February 7, 2018

First Posted (ACTUAL)

February 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P16012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plans

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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