Healthy SubjectsPhase 1NCT04617782
Pharmacokinetic Study of 5 and 10 mg Corplex™ Donepezil TDS Compared to 10 mg Aricept® in Healthy Volunteers
A Phase 1 study testing Donepezil TDS and Aricept in people with Healthy Subjects, run by Corium, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Donepezil TDS and Aricept
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2020to 5 Apr 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 TDS Compared to 10 mg Oral Aricept® in Healthy Volunteers
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.
Read the 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
- Being tested
- Donepezil TDS, Aricept
- Keywords
- Donepezil, Transdermal Delivery System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil TDSCombination product
Transdermal Delivery System
AriceptDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 5 mg/day Donepezil Transdermal Delivery System (TDS) 1-week wear and applied weekly for 5 consecutive weeks Receives: Combination Product: Donepezil TDS |
| Treatment B | Experimental | 10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks Receives: Combination Product: Donepezil TDS |
| Treatment C | Active comparator | 10 mg/day Aricept® donepezil tablet administered QD for 5 consecutive weeks Receives: Drug: Aricept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration (Cmax)
To evaluate steady-state donepezil plasma exposure (Cmax) following 5 weeks of treatment.
Measured: 35 days of each Treatment
Area Under the Curve (AUC)
To evaluate steady-state donepezil plasma exposure (AUC) following 5 weeks of treatment
Measured: 35 days each Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start8 Dec 2020
- Primary completion5 Apr 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Phase 1, open-label, randomized, 3-period, 3-treatment, crossover PK study to evaluate the steady-state pharmacokinetics
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corium, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Bass, MD, Principal investigator, Worldwide Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617782
- Sponsor's protocol ID
- CL-P-20003
- Status last verified
- Apr 2024
- First submitted
- 1 Nov 2020
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 36120781
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 TDS Compared to 10 mg Oral Aricept® in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04617782
- Acronym / sponsor ID
- CL-P-20003
- Conditions
- Healthy Subjects
- Keywords
- Donepezil, Transdermal Delivery System
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Corium, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase 1, open-label, randomized, 3-period, 3-treatment, crossover PK study to evaluate the steady-state pharmacokinetics
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Combination Product: Donepezil TDS5 mg/day Donepezil Transdermal Delivery System (TDS) 1-week wear and applied weekly for 5 consecutive weeks |
| Treatment B | Experimental | Combination Product: Donepezil TDS10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks |
| Treatment C | Active comparator | Drug: Aricept10 mg/day Aricept® donepezil tablet administered QD for 5 consecutive weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil TDSTransdermal Delivery System | Combination product | Treatment A, Treatment B |
| AriceptOral | Drug | Treatment C |
Primary outcome
Maximum Concentration (Cmax)
Time frame: 35 days of each Treatment
To evaluate steady-state donepezil plasma exposure (Cmax) following 5 weeks of treatment.
Area Under the Curve (AUC)
Time frame: 35 days each Treatment
To evaluate steady-state donepezil plasma exposure (AUC) following 5 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36120781Tariot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bass, MD principal investigator
Worldwide Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Donepezil TDS and Aricept in people with Healthy Subjects, run by Corium, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Concentration (Cmax) (time frame: 35 days of each Treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04617782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.