Clincosm LogoSign in Get a demo

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

Sponsor
Corium, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04617782
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
3.9
Actual Duration (Months)
15.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Phase 1, open-label, randomized, 3-period, 3-treatment, crossover PK study to evaluate the steady-state pharmacokineticsPhase 1, open-label, randomized, 3-period, 3-treatment, crossover PK study to evaluate the steady-state pharmacokinetics
Masking:
None (Open Label)
Masking Description:
open label
Primary Purpose:
Other
Official Title:
A Phase 1, Open-Label, 3-Period, Randomized, Crossover Pharmacokinetic Study to Evaluate the Steady-State Pharmacokinetics of 5 mg and 10 mg Corplex™ Donepezil Transdermal Delivery Systems Compared to 10 mg Oral Administration of Aricept® in Healthy Volunteers
Actual Study Start Date :
Dec 8, 2020
Actual Primary Completion Date :
Apr 5, 2021
Actual Study Completion Date :
Apr 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment A

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

Combination Product: Donepezil TDS
Transdermal Delivery System
Experimental: Treatment B

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

Combination Product: Donepezil TDS
Transdermal Delivery System
Active Comparator: Treatment C

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

Drug: Aricept
Oral

Outcome Measures

Primary Outcome Measures

  1. Steady State Bioequivalence of 10 mg/day donepezil [35 days of Treatment of each comparator]

    To evaluate steady-state donepezil plasma exposure following once-weekly treatments with 10 mg/day Corplex™ Donepezil TDS compared to once-daily oral administration of 10 mg Aricept®

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 QTcF 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Worldwide Clinical Trials San Antonio Texas United States 78217

Sponsors and Collaborators

  • Corium, Inc.

Investigators

  • Principal Investigator: Robert Bass, MD, Worldwide Clinical Trials

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Corium, Inc.
ClinicalTrials.gov Identifier:
NCT04617782
Other Study ID Numbers:
  • CL-P-20003
First Posted:
Nov 5, 2020
Last Update Posted:
May 21, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Corium, Inc.
Donepezil, Transdermal Delivery System
Additional relevant MeSH terms:
Donepezil

Study Results

No Results Posted as of May 21, 2021