Pharmacokinetic Study of 5 and 10 mg Corplex™ Donepezil TDS Compared to 10 mg Aricept® in Healthy Volunteers

NCT04617782 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CL-P-20003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1, open-label, randomized, 3-period, 3-treatment, crossover pharmacokinetic study to evaluate the steady-state pharmacokinetics of 5 mg/day and 10 mg/day Corplex™ Donepezil TDS manufactured with the commercial process compared to 10 mg Aricept® in healthy volunteers.

Conditions

Healthy Subjects

Keywords

Donepezil, Transdermal Delivery System

Outcome Measures

Primary Outcomes (2)

• Maximum Concentration (Cmax)

  To evaluate steady-state donepezil plasma exposure (Cmax) following 5 weeks of treatment.

  35 days of each Treatment

• Area Under the Curve (AUC)

  To evaluate steady-state donepezil plasma exposure (AUC) following 5 weeks of treatment

  35 days each Treatment

Study Arms (3)

Treatment A

EXPERIMENTAL

5 mg/day Donepezil Transdermal Delivery System (TDS) 1-week wear and applied weekly for 5 consecutive weeks

Combination Product: Donepezil TDS

Treatment B

EXPERIMENTAL

10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks

Combination Product: Donepezil TDS

Treatment C

ACTIVE COMPARATOR

10 mg/day Aricept® donepezil tablet administered QD for 5 consecutive weeks

Drug: Aricept

Interventions

Donepezil TDS COMBINATION_PRODUCT

Transdermal Delivery System

Treatment A; Treatment B

Aricept DRUG

Oral

Treatment C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females.
• Subject's Body Mass Index (BMI) must be between 18 and 32 kg/m2 (inclusive).
• Subject must be continuous non-smokers.
• Subject must have a Fitzpatrick skin type of I, II or III.

You may not qualify if:

• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
• After resting seated for at least 3 minutes, subjects should be excluded from the study with the following vital signs at Screening
• systolic blood pressure outside the range of 90-145 mmHg, or
• diastolic blood pressure outside the range of 50-90 mmHg, or
• resting heart rate outside the range of 40-100 beats per minute.
• Has an isolated ALT ≥1.5x the ULN or AST ≥1.5x the ULN at Screening; or both ALT and AST exceeding the ULN.
• Estimated creatinine clearance at screening \<70 mL/min/1.73 m2.
• Prolonged corrected QT (Fridericia) on screening ECG (≥450 ms for both females and males).
• History or presence of excessive hairy skin on application sites as deemed by the Investigator to potentially interfere with patch adhesion or drug absorption.
• History or presence of significant skin damage, diffuse skin diseases-, scars, tattoos on the application sites or other skin disturbances as deemed by the Investigator to potentially interfere with drug absorption or skin tolerability assessments
• Use of donepezil hydrochloride or related drugs within 60 days prior to the first study drug administration.
• Has participated in another clinical trial within 30 days prior to Day -1.

Sponsors & Collaborators

• Corium, Inc.: lead

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

Related Publications (1)

• Tariot PN, Braeckman R, Oh C. Comparison of Steady-State Pharmacokinetics of Donepezil Transdermal Delivery System with Oral Donepezil. J Alzheimers Dis. 2022;90(1):161-172. doi: 10.3233/JAD-220530.

  PMID: 36120781 DERIVED

MeSH Terms

Interventions

Donepezil

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ronald Tashjian, Sr. Director of Clinical Operations
• Organization: Corium, Inc.

rtashjian@coriumintl.com

6172337474

Study Officials

• Robert Bass, MD

  Worldwide Clinical Trials

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Model Details: Phase 1, open-label, randomized, 3-period, 3-treatment, crossover PK study to evaluate the steady-state pharmacokinetics

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 5, 2020
• Study Start: December 8, 2020
• Primary Completion: April 5, 2021
• Study Completion: April 5, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Locations

US (1)