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

NCT03259958 | Completed Phase 1 FDA Drug

• 1 other identifier: P-16010
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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®

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• PK, AUC

  To assess the plasma concentration (AUC) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride \[HCl\]).

  Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total

• 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 \[HCl\]).

  Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total

Secondary Outcomes (3)

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

  Daily during 5 week treatment period and during the 5 week follow-on period

• PI assessment of local skin irritation response to TDS

  0.5hr, 24hr, 48hr and 72hr after each TDS removal. (5 consecutive weeks)

• PI assessment of TDS Adhesion

  Daily during 5 week treatment period

Study Arms (2)

Donepezil TDS

EXPERIMENTAL

Corplex Donepezil TDS 5 mg/day followed by Donepezil TDS 10mg/day applied weekly for 5 consecutive weeks

Drug: Donepezil TDS

Aricept

ACTIVE COMPARATOR

Aricept 5 mg/day followed by Aricept 10 mg/day once daily for 5 consecutive weeks

Drug: Aricept

Interventions

Donepezil TDS DRUG

Donepezil Hydrochloride Transdermal Delivery System

Donepezil TDS

Aricept DRUG

Aricept Tablet

Aricept

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.
• 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;

Sponsors & Collaborators

• Corium, Inc.: lead

Study Sites (1)

Celerion Inc.

Phoenix, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Danielle Armas, MD

  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: August 21, 2017
• First Posted: August 24, 2017
• Study Start: October 30, 2017
• Primary Completion: March 13, 2018
• Study Completion: March 14, 2018
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)