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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03432195
Recruitment Status : Completed
First Posted : February 14, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Corium, Inc.

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Donepezil TDS Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations
Actual Study Start Date : January 31, 2018
Actual Primary Completion Date : June 28, 2018
Actual Study Completion Date : June 28, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432195


Locations
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United States, Arizona
Celerion
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Corium, Inc.
Investigators
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Principal Investigator: Danielle Armas Celerion
More Information
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Responsible Party: Corium, Inc.
ClinicalTrials.gov Identifier: NCT03432195    
Other Study ID Numbers: P16012
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plans

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
 Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents