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

NCT ID: NCT04617782

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-08
• Study Completion Date: 2021-04-05

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.

Detailed Description

Screening Period:

Subjects will undergo a Screening Period up to 28 days prior to entering the Treatment Phase.

Treatment Phase consisting of 3 Treatment periods with 3 Treatments A, B, C.

Treatment Period 1: All Subjects will receive Treatment A; 5 mg/day Donepezil Transdermal Delivery System (TDS); 1-week wear and applied for 5 consecutive weeks.

Treatment Periods 2 and 3: Subjects will be randomized (by gender) to receive either sequences of Treatments B-C or Treatments C-B.

Treatment B: 10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks Treatment C: 10 mg/day Aricept® donepezil tablet administered daily (QD) for 5 weeks.

Blood samples for pharmacokinetics and safety assessments will be collected during the Treatment Phase.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment A

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

Group Type: EXPERIMENTAL

Donepezil TDS

Intervention Type: COMBINATION_PRODUCT

Transdermal Delivery System

Treatment B

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

Group Type: EXPERIMENTAL

Donepezil TDS

Intervention Type: COMBINATION_PRODUCT

Transdermal Delivery System

Treatment C

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

Group Type: ACTIVE_COMPARATOR

Aricept

Intervention Type: DRUG

Oral

Interventions

Donepezil TDS

Transdermal Delivery System

Intervention Type: COMBINATION_PRODUCT

Aricept

Oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

1. systolic blood pressure outside the range of 90-145 mmHg, or

2. diastolic blood pressure outside the range of 50-90 mmHg, or

3. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Corium, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Bass, MD

Role: PRINCIPAL_INVESTIGATOR

Worldwide Clinical Trials

Locations

Worldwide Clinical Trials

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36120781 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CL-P-20003

Identifier Type: -

Identifier Source: org_study_id