Alzheimer's DiseasePhase 1NCT03259958
A Bioequivalence Study of Corplex™ Donepezil Transdermal Delivery System Compared to Aricept®
A Phase 1 study testing Donepezil TDS and Aricept in people with Alzheimer's Disease, run by Corium, Inc. at 1 site in United States.
Trial summary
A study to assess the steady-state bioequivalence of once-weekly Corplex™ Donepezil 10 mg Transdermal Delivery System (TDS) compared to daily administration of Aricept® Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- 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
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 14 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, adult, male or female
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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;
- Prolia;
- adjuvant analgesics
- Muscle relaxants, anti-Parkinsonian or neuroleptic medications prior to the first dose of study drug
- History or presence of excessive hairy skin on application sites as deemed by the Investigator to potentially interfere with 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 irritation assessments
- Use of donepezil hydrochloride or related drugs within 30 days prior to the first study drug administration
- Participation in another clinical study within 30 days prior to the first study drug administration
- Clinically significant depression symptoms or suicidal ideation or behavior as determined by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess the Steady-State Bioequivalence of Once-Weekly Corplex™ 10mg Donepezil Transdermal Delivery System Compared to Daily Oral Administration of Aricept®
A study to assess the steady-state bioequivalence of once-weekly Corplex™ Donepezil 10 mg Transdermal Delivery System (TDS) compared to daily administration of Aricept®
Read the detailed description
Open label, randomized, 2-period, multiple-dose crossover study.
Approximately 86 healthy, adult male and female subjects will be enrolled.
Subjects will be randomized to 1 of 2 treatment sequences prior to the first study product treatment in treatment period 1.
For each treatment period; subjects will receive donepezil for 5 consecutive weeks. Blood samples for donepezil PK will be collected pre-dose through week 10.
Adhesion and skin irritation will be monitored throughout TDS treatments. Safety will be monitored throughout the study by adverse event reporting, repeated clinical and laboratory evaluations.
- Conditions
- Alzheimer's Disease
- Being tested
- Donepezil TDS, Aricept
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil TDSDrug
Donepezil Hydrochloride Transdermal Delivery System
AriceptDrug
Aricept Tablet
| Study group | Role | What they receive |
|---|---|---|
| Donepezil TDS | Experimental | Corplex Donepezil TDS 5 mg/day followed by Donepezil TDS 10mg/day applied weekly for 5 consecutive weeks Receives: Drug: Donepezil TDS |
| Aricept | Active comparator | Aricept 5 mg/day followed by Aricept 10 mg/day once daily for 5 consecutive weeks Receives: Drug: Aricept |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK, AUC
To assess the plasma concentration (AUC) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride [HCl]).
Measured: Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total
PK, Cmax
To assess the maximum observed concentrations (Cmax) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride [HCl]).
Measured: Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total
Secondary outcomes (3)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
General Safety (AE and SAE as reported by subject following guidance CTCAE v4.0)
Measured: Daily during 5 week treatment period and during the 5 week follow-on period
PI assessment of local skin irritation response to TDS
To evaluate the safety and tolerability (including local skin irritation) of once-weekly Corplex Donepezil TDS. Dermal Response assessed using 8 point categorical scale. Other effects assessed using a 6 point scale.
Measured: 0.5hr, 24hr, 48hr and 72hr after each TDS removal. (5 consecutive weeks)
PI assessment of TDS Adhesion
Adhesion data will be collected during each 7-day patch wear period throughout 5 week treatment period. Percent adherence will be assessed using 12 point categorical scale.
Measured: Daily during 5 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start30 Oct 2017
- Primary completion13 Mar 2018
- Study completion14 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corium, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danielle Armas, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259958
- Sponsor's protocol ID
- P-16010
- Status last verified
- Jul 2018
- First submitted
- 21 Aug 2017
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No Plans
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Steady-State Bioequivalence of Once-Weekly Corplex™ 10mg Donepezil Transdermal Delivery System Compared to Daily Oral Administration of Aricept®
- ClinicalTrials.gov ID
- NCT03259958
- Acronym / sponsor ID
- P-16010
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Corium, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess the steady-state bioequivalence of once-weekly Corplex™ Donepezil 10 mg Transdermal Delivery System (TDS) compared to daily administration of Aricept®
Detailed description
Open label, randomized, 2-period, multiple-dose crossover study.
Approximately 86 healthy, adult male and female subjects will be enrolled.
Subjects will be randomized to 1 of 2 treatment sequences prior to the first study product treatment in treatment period 1.
For each treatment period; subjects will receive donepezil for 5 consecutive weeks. Blood samples for donepezil PK will be collected pre-dose through week 10.
Adhesion and skin irritation will be monitored throughout TDS treatments. Safety will be monitored throughout the study by adverse event reporting, repeated clinical and laboratory evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donepezil TDS | Experimental | Drug: Donepezil TDSCorplex Donepezil TDS 5 mg/day followed by Donepezil TDS 10mg/day applied weekly for 5 consecutive weeks |
| Aricept | Active comparator | Drug: AriceptAricept 5 mg/day followed by Aricept 10 mg/day once daily for 5 consecutive weeks |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy, adult, male or female
- 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
Key exclusion criteria (23 listed)
- 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
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 TDSDonepezil Hydrochloride Transdermal Delivery System | Drug | Donepezil TDS |
| AriceptAricept Tablet | Drug | Aricept |
Primary outcome
PK, AUC
Time frame: Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total
To assess the plasma concentration (AUC) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride [HCl]).
PK, Cmax
Time frame: Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total
To assess the maximum observed concentrations (Cmax) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride [HCl]).
3 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Daily during 5 week treatment period and during the 5 week follow-on period
PI assessment of local skin irritation response to TDS
Time frame: 0.5hr, 24hr, 48hr and 72hr after each TDS removal. (5 consecutive weeks)
PI assessment of TDS Adhesion
Time frame: Daily during 5 week treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Individual participant dataSharing planned: No. No Plans
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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.
Danielle Armas, MD principal investigator
Celerion
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 Alzheimer's Disease, 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 23 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 1 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PK, AUC (time frame: Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total). 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?
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 1 Aug 2018; AzTrials last refreshed its copy on 31 Oct 2026.