A Phase 1, Corplex™ Donepezil Transdermal System Compared to Oral Aricept®

NCT02968719 | Completed Phase 1

• 1 other identifier: P-15086
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, Randomized, Open-Label, 3-Way Crossover, Pilot, Pharmacokinetic Study to Evaluate the Steady State Pharmacokinetics of a Once-Weekly Application of Corplex Donepezil Transdermal Delivery System (TDS) Compared to Daily Oral Administration of Aricept in Healthy Adult Subjects

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Steady-state PK

  To evaluate the steady-state PK of donepezil following once weekly Corplex Donepezil TDS application compared to once-daily (QD) oral administration of Aricept. Aricept PK sampling time points; Day 1 (hr0,1,2,3,4,6,8,12); Day 2,8,15,22,29 (hr0); Day 35(hr0,1,2,3,4,6,8,12); Day 36-37,40,43,46,49,53 (hr0)

  TDS PK sampling time-points: Predose; Day 1 (hr0); Post-dose; Day 1 (hr2,6,12); Day 2-15,22 (hr0); Day 29 (hr0,3,6,12); Day 30-35 (hr0,12) Day 36 (hr0, 2,6,12); Day 37-38,41,44,47,50,54 (hr0);

• PK (Part B)

  To compare the PK of 2 once-weekly Corplex Donepezil TDS treatments (target dose 5 mg donepezil/day)

  TDS PK sampling time-points: Predose; Day 1 (hr0); Post-dose; Day 1 (hr2,6,12); Day 2-8 (hr0,12); Day 9,10,11,13,16,19,22,26,30,36 (hr0)

Secondary Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (Part A and B)

  Daily during 36-day confinement period and 7 visits over the 21 day wash-out period.

• PI assessment of local skin irritation response to TDS (Part A and B)

  Part A: Daily during 36-day confinement period and 7 visits over the 21 day wash-out period. Part B:Daily during 10-day confinement period and 8 visits over the 28-35 day wash-out period.

• PI assessment of TDS Adhesion per FDA UCM504157

  Twice daily during 36-day confinement period

Study Arms (5)

Donepezil TDS Version A

EXPERIMENTAL

Lead-in of 5 mg/day donepezil of target dose (1 x Corplex 5 mg donepezil transdermal delivery system; 7 days) followed by; Target dose of 10 mg/day donepezil (Treatment A); Corplex 10 mg donepezil transdermal delivery system. 1x patch will be worn for 7 days. A total of 4 TDS patches will be applied for 4 consecutive 7 day periods.

Drug: Donepezil TDS Version B; Drug: Aricept

Donepezil TDS Version B

EXPERIMENTAL

Lead-in of 5 mg/day donepezil of target dose (1 x Corplex 5 mg donepezil transdermal delivery system; 7 days) followed by; Target dose of 10 mg/day donepezil (Treatment B); Corplex 10 mg donepezil delivery transdermal system. 1x patch will be worn for 7 days. A total of 4 TDS patches will be applied for 4 consecutive 7 day periods.

Drug: Donepezil TDS Version A; Drug: Aricept

10 mg Aricept

ACTIVE COMPARATOR

5 mg/day oral Aricept, once daily for 7 days followed by; 10 mg/day Aricept once daily for 28 days

Drug: Donepezil TDS Version A; Drug: Donepezil TDS Version B

Donepezil TDS Version D

EXPERIMENTAL

Target dose of 5 mg/day donepezil (Treatment D) Corplex 5 mg Donepezil TDS applied for a duration of 1 week.

Drug: Donepezil TDS Version D; Drug: Donepezil TDS Version E

Donepezil TDS Version E

EXPERIMENTAL

Target dose of 5 mg/day donepezil (Treatment E) Corplex 5 mg Donepezil TDS applied for a duration of 1 week

Drug: Donepezil TDS Version D; Drug: Donepezil TDS Version E

Interventions

Donepezil TDS Version A DRUG

Donepezil Hydrochloride Transdermal Delivery System (5mg and 10 mg Version B)

10 mg Aricept; Donepezil TDS Version B

Donepezil TDS Version B DRUG

Donepezil Hydrochloride Transdermal Delivery System (5 mg and 10 mg Version B)

10 mg Aricept; Donepezil TDS Version A

Aricept DRUG

Aricept (5 mg and 10 mg) Donepezil Hydrochloride

Also known as: Aricept Tablet

Donepezil TDS Version A; Donepezil TDS Version B

Donepezil TDS Version D DRUG

Donepezil Hydrochloride Transdermal Delivery System (5 mg Version D)

Donepezil TDS Version D; Donepezil TDS Version E

Donepezil TDS Version E DRUG

Donepezil Hydrochloride Transdermal Delivery System (5 mg Version E)

Donepezil TDS Version D; Donepezil TDS Version E

Eligibility Criteria

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

You may qualify if:

• Healthy, adult, Caucasian, male or female ≥18 years of age at screening
• 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

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
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2016
• First Posted: November 21, 2016
• Study Start: November 1, 2016
• Primary Completion: July 11, 2017
• Study Completion: July 11, 2017
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)