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

NCT03432195 | Completed Phase 1 FDA Drug

• 1 other identifier: P16012
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics, AUC

  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

  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 Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by 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

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

• Application Site Mean Adhesion Scores of Donepezil Corplex TDS

  Daily during 1 week treatment period

Study Arms (3)

Donepezil TDS Back

EXPERIMENTAL

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

Drug: Donepezil TDS

Donepezil TDS Buttock

EXPERIMENTAL

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

Drug: Donepezil TDS

Donepezil TDS Leg

EXPERIMENTAL

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

Drug: Donepezil TDS

Interventions

Donepezil TDS DRUG

Donepezil Hydrochloride Transdermal Delivery System

Donepezil TDS Back; Donepezil TDS Buttock; Donepezil TDS Leg

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corium, Inc.: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Danielle Armas

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 14, 2018
• Study Start: January 31, 2018
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)