Alzheimer DiseasePhase 1NCT02968719
A Phase 1, Corplex™ Donepezil Transdermal System Compared to Oral Aricept®
A Phase 1 study testing Donepezil TDS Version A, Donepezil TDS Version B and Aricept in people with Alzheimer Disease, run by Corium, Inc. at 1 site in United States.
Trial summary
A Phase 1, Randomized, Open-Label, 3-Way Crossover, Pilot, Pharmacokinetic Study to Evaluate the Steady State Pharmacokinetics of a Once-Weekly Application of Corplex Donepezil Transdermal Delivery System (TDS) Compared to Daily Oral Administration of Aricept in Healthy Adult Subjects Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Donepezil TDS Version A, Donepezil TDS Version B and Aricept
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 11 Jul 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, adult, Caucasian, male or female ≥18 years of age at screening
- 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 60 days prior to the first study drug administration
- Participation in another clinical study within 60 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: Phase 1 Pharmacokinetic (PK) Study to Evaluate Once-weekly Corplex™ Donepezil Transdermal Delivery System Compared to Daily Oral Administration of Aricept® in Healthy Adult Subjects
A Phase 1, Randomized, Open-Label, 3-Way Crossover, Pilot, Pharmacokinetic Study to Evaluate the Steady State Pharmacokinetics of a Once-Weekly Application of Corplex Donepezil Transdermal Delivery System (TDS) Compared to Daily Oral Administration of Aricept in Healthy Adult Subjects
Read the detailed description
Part A:
60 male and female subjects will be enrolled Subjects will receive 2 versions of once-weekly Corplex Donepezil TDS and QD oral Aricept; each administered for 35 days in 3 different treatment periods.
For each treatment period; Subjects will receive a lead-in dose of approximately 5 mg donepezil/day for 7 days before commencing a dose of 10 mg donepezil/day for 28 days. Blood samples for donepezil PK and red blood cell (RBC) AChEI (as a potential pharmacodynamic [PD] marker) will be collected pre-dose through Week 8.
Adhesion and skin irritation will be monitored throughout TDS Treatments. A washout period of at least 21 days between the last study drug administration (oral administration or removal of TDS, as appropriate) in each treatment period and the first application of TDS or oral drug administration, as appropriate, in the following treatment period.
Safety will be monitored throughout the study by adverse event reporting, repeated clinical and laboratory evaluations
Part B:
Up to 47 subjects male and/or female will be enrolled This is an open-label, randomized, 2-way crossover sub-study. Eligible subjects will be randomized to 1 of 2 treatment sequences prior to the first TDS application.
Subjects will receive 2 different once-weekly Corplex Donepezil TDS treatments (Treatments D and E), each administered for 1 week, in 2 different treatment periods (Treatment Period 1 and Treatment Period 2).
In each treatment period, subjects will receive a target dose of 5 mg donepezil/day for 7 days. There will be a washout period of 35 days between removal of the first TDS in Treatment Period 1 and application of the second TDS in Treatment Period 2.
Blood samples for donepezil PK will be collected pre-dose and through to Week 6 of each treatment period.
Safety will be monitored throughout the sub-study by repeated clinical, skin irritation and laboratory evaluations.
- Conditions
- Alzheimer Disease
- Being tested
- Donepezil TDS Version A, Donepezil TDS Version B, Aricept, Donepezil TDS Version D, Donepezil TDS Version E
- 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 TDS Version ADrug
Donepezil Hydrochloride Transdermal Delivery System (5mg and 10 mg Version B)
Donepezil TDS Version BDrug
Donepezil Hydrochloride Transdermal Delivery System (5 mg and 10 mg Version B)
AriceptDrug
Also called Aricept Tablet
Aricept (5 mg and 10 mg) Donepezil Hydrochloride
Donepezil TDS Version DDrug
Donepezil Hydrochloride Transdermal Delivery System (5 mg Version D)
Donepezil TDS Version EDrug
Donepezil Hydrochloride Transdermal Delivery System (5 mg Version E)
| Study group | Role | What they receive |
|---|---|---|
| Donepezil TDS Version A | Experimental | Lead-in of 5 mg/day donepezil of target dose (1 x Corplex 5 mg donepezil transdermal delivery system; 7 days) followed by; Target dose of 10 mg/day donepezil (Treatment A); Corplex 10 mg donepezil transdermal delivery system.
1x patch will be worn for 7 days. A total of 4 TDS patches will be applied for 4 consecutive 7 day periods. Receives: Drug: Donepezil TDS Version B; Drug: Aricept |
| Donepezil TDS Version B | Experimental | Lead-in of 5 mg/day donepezil of target dose (1 x Corplex 5 mg donepezil transdermal delivery system; 7 days) followed by; Target dose of 10 mg/day donepezil (Treatment B); Corplex 10 mg donepezil delivery transdermal system.
1x patch will be worn for 7 days. A total of 4 TDS patches will be applied for 4 consecutive 7 day periods. Receives: Drug: Donepezil TDS Version A; Drug: Aricept |
| 10 mg Aricept | Active comparator | 5 mg/day oral Aricept, once daily for 7 days followed by; 10 mg/day Aricept once daily for 28 days Receives: Drug: Donepezil TDS Version A; Drug: Donepezil TDS Version B |
| Donepezil TDS Version D | Experimental | Target dose of 5 mg/day donepezil (Treatment D) Corplex 5 mg Donepezil TDS applied for a duration of 1 week. Receives: Drug: Donepezil TDS Version D; Drug: Donepezil TDS Version E |
| Donepezil TDS Version E | Experimental | Target dose of 5 mg/day donepezil (Treatment E) Corplex 5 mg Donepezil TDS applied for a duration of 1 week Receives: Drug: Donepezil TDS Version D; Drug: Donepezil TDS Version E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady-state PK
To evaluate the steady-state PK of donepezil following once weekly Corplex Donepezil TDS application compared to once-daily (QD) oral administration of Aricept.
Aricept PK sampling time points; Day 1 (hr0,1,2,3,4,6,8,12); Day 2,8,15,22,29 (hr0); Day 35(hr0,1,2,3,4,6,8,12); Day 36-37,40,43,46,49,53 (hr0)
Measured: TDS PK sampling time-points: Predose; Day 1 (hr0); Post-dose; Day 1 (hr2,6,12); Day 2-15,22 (hr0); Day 29 (hr0,3,6,12); Day 30-35 (hr0,12) Day 36 (hr0, 2,6,12); Day 37-38,41,44,47,50,54 (hr0);
PK (Part B)
To compare the PK of 2 once-weekly Corplex Donepezil TDS treatments (target dose 5 mg donepezil/day)
Measured: TDS PK sampling time-points: Predose; Day 1 (hr0); Post-dose; Day 1 (hr2,6,12); Day 2-8 (hr0,12); Day 9,10,11,13,16,19,22,26,30,36 (hr0)
Secondary outcomes (3)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (Part A and B)
General Safety (AE and SAE as reported by subject following guidance CTCAE v4.0)
Measured: Daily during 36-day confinement period and 7 visits over the 21 day wash-out period.
PI assessment of local skin irritation response to TDS (Part A and B)
To evaluate the safety and tolerability (including local skin irritation) of once-weekly Corplex Donepezil TDS. Skin irritation assessed using 8 pt categorical scale based on former FDA.gov/ohrms/dockets/98fr/990236GD.pdf. The Skin Irritation scale is: no irritation; minimal erythema/barely perceptible; definite erythema readily visible, minimal edema or minimal papular response; erythema and papules; definite edema; erythema, edema and papules; vesicular eruption; strong reaction spreading beyond application site.
Measured: Part A: Daily during 36-day confinement period and 7 visits over the 21 day wash-out period. Part B:Daily during 10-day confinement period and 8 visits over the 28-35 day wash-out period.
PI assessment of TDS Adhesion per FDA UCM504157
To evaluate the adhesion of once-weekly Corplex Donepezil TDS. Adhesion is based on the adhered area (%) of the patch according to FDA.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/UCM504157.pdf. Specifically: ≥ 90% adhered (essentially no lift off skin); ≥ 75% to <90% adhered (some edges only lifting off skin); ≥ 50% to <75% adhered (less than half the TDS lifting off skin); < 50% adhered but did not detach (not detached, but more than half of the TDS lifting off skin without falling off); patch completely detached (TDS detached, completely off skin).
Measured: Twice daily during 36-day confinement period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion11 Jul 2017
- Study completion11 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- 107 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
- NCT02968719
- Sponsor's protocol ID
- P-15086
- Status last verified
- Jul 2018
- First submitted
- 13 Nov 2016
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- 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
- Phase 1 Pharmacokinetic (PK) Study to Evaluate Once-weekly Corplex™ Donepezil Transdermal Delivery System Compared to Daily Oral Administration of Aricept® in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02968719
- Acronym / sponsor ID
- P-15086
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Corium, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- 11 Jul 2017 (actual)
- Study completion
- 11 Jul 2017 (actual)
- First posted
- 21 Nov 2016 (estimated)
- 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 Phase 1, Randomized, Open-Label, 3-Way Crossover, Pilot, Pharmacokinetic Study to Evaluate the Steady State Pharmacokinetics of a Once-Weekly Application of Corplex Donepezil Transdermal Delivery System (TDS) Compared to Daily Oral Administration of Aricept in Healthy Adult Subjects
Detailed description
Part A:
60 male and female subjects will be enrolled Subjects will receive 2 versions of once-weekly Corplex Donepezil TDS and QD oral Aricept; each administered for 35 days in 3 different treatment periods.
For each treatment period; Subjects will receive a lead-in dose of approximately 5 mg donepezil/day for 7 days before commencing a dose of 10 mg donepezil/day for 28 days. Blood samples for donepezil PK and red blood cell (RBC) AChEI (as a potential pharmacodynamic [PD] marker) will be collected pre-dose through Week 8.
Adhesion and skin irritation will be monitored throughout TDS Treatments. A washout period of at least 21 days between the last study drug administration (oral administration or removal of TDS, as appropriate) in each treatment period and the first application of TDS or oral drug administration, as appropriate, in the following treatment period.
Safety will be monitored throughout the study by adverse event reporting, repeated clinical and laboratory evaluations
Part B:
Up to 47 subjects male and/or female will be enrolled This is an open-label, randomized, 2-way crossover sub-study. Eligible subjects will be randomized to 1 of 2 treatment sequences prior to the first TDS application.
Subjects will receive 2 different once-weekly Corplex Donepezil TDS treatments (Treatments D and E), each administered for 1 week, in 2 different treatment periods (Treatment Period 1 and Treatment Period 2).
In each treatment period, subjects will receive a target dose of 5 mg donepezil/day for 7 days. There will be a washout period of 35 days between removal of the first TDS in Treatment Period 1 and application of the second TDS in Treatment Period 2.
Blood samples for donepezil PK will be collected pre-dose and through to Week 6 of each treatment period.
Safety will be monitored throughout the sub-study by repeated clinical, skin irritation and laboratory evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Donepezil TDS Version A | Experimental | Drug: Donepezil TDS Version B, Drug: AriceptLead-in of 5 mg/day donepezil of target dose (1 x Corplex 5 mg donepezil transdermal delivery system; 7 days) followed by; Target dose of 10 mg/day donepezil (Treatment A); Corplex 10 mg donepezil transdermal delivery system. 1x patch will be worn for 7 days. A total of 4 TDS patches will be applied for 4 consecutive 7 day periods. |
| Donepezil TDS Version B | Experimental | Drug: Donepezil TDS Version A, Drug: AriceptLead-in of 5 mg/day donepezil of target dose (1 x Corplex 5 mg donepezil transdermal delivery system; 7 days) followed by; Target dose of 10 mg/day donepezil (Treatment B); Corplex 10 mg donepezil delivery transdermal system. 1x patch will be worn for 7 days. A total of 4 TDS patches will be applied for 4 consecutive 7 day periods. |
| 10 mg Aricept | Active comparator | Drug: Donepezil TDS Version A, Drug: Donepezil TDS Version B5 mg/day oral Aricept, once daily for 7 days followed by; 10 mg/day Aricept once daily for 28 days |
| Donepezil TDS Version D | Experimental | Drug: Donepezil TDS Version D, Drug: Donepezil TDS Version ETarget dose of 5 mg/day donepezil (Treatment D) Corplex 5 mg Donepezil TDS applied for a duration of 1 week. |
| Donepezil TDS Version E | Experimental | Drug: Donepezil TDS Version D, Drug: Donepezil TDS Version ETarget dose of 5 mg/day donepezil (Treatment E) Corplex 5 mg Donepezil TDS applied for a duration of 1 week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy, adult, Caucasian, male or female ≥18 years of age at screening
- 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 TDS Version ADonepezil Hydrochloride Transdermal Delivery System (5mg and 10 mg Version B) | Drug | 10 mg Aricept, Donepezil TDS Version B |
| Donepezil TDS Version BDonepezil Hydrochloride Transdermal Delivery System (5 mg and 10 mg Version B) | Drug | 10 mg Aricept, Donepezil TDS Version A |
| AriceptAlso: Aricept TabletAricept (5 mg and 10 mg) Donepezil Hydrochloride | Drug | Donepezil TDS Version A, Donepezil TDS Version B |
| Donepezil TDS Version DDonepezil Hydrochloride Transdermal Delivery System (5 mg Version D) | Drug | Donepezil TDS Version D, Donepezil TDS Version E |
| Donepezil TDS Version EDonepezil Hydrochloride Transdermal Delivery System (5 mg Version E) | Drug | Donepezil TDS Version D, Donepezil TDS Version E |
Primary outcome
Steady-state PK
Time frame: TDS PK sampling time-points: Predose; Day 1 (hr0); Post-dose; Day 1 (hr2,6,12); Day 2-15,22 (hr0); Day 29 (hr0,3,6,12); Day 30-35 (hr0,12) Day 36 (hr0, 2,6,12); Day 37-38,41,44,47,50,54 (hr0);
To evaluate the steady-state PK of donepezil following once weekly Corplex Donepezil TDS application compared to once-daily (QD) oral administration of Aricept. Aricept PK sampling time points; Day 1 (hr0,1,2,3,4,6,8,12); Day 2,8,15,22,29 (hr0); Day 35(hr0,1,2,3,4,6,8,12); Day 36-37,40,43,46,49,53 (hr0)
PK (Part B)
Time frame: TDS PK sampling time-points: Predose; Day 1 (hr0); Post-dose; Day 1 (hr2,6,12); Day 2-8 (hr0,12); Day 9,10,11,13,16,19,22,26,30,36 (hr0)
To compare the PK of 2 once-weekly Corplex Donepezil TDS treatments (target dose 5 mg donepezil/day)
3 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (Part A and B)
Time frame: Daily during 36-day confinement period and 7 visits over the 21 day wash-out period.
PI assessment of local skin irritation response to TDS (Part A and B)
Time frame: Part A: Daily during 36-day confinement period and 7 visits over the 21 day wash-out period. Part B:Daily during 10-day confinement period and 8 visits over the 28-35 day wash-out period.
PI assessment of TDS Adhesion per FDA UCM504157
Time frame: Twice daily during 36-day confinement 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 Version A, Donepezil TDS Version B and Aricept in people with Alzheimer 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?
Steady-state PK (time frame: TDS PK sampling time-points: Predose; Day 1 (hr0); Post-dose; Day 1 (hr2,6,12); Day 2-15,22 (hr0); Day 29 (hr0,3,6,12); Day 30-35 (hr0,12) Day 36 (hr0, 2,6,12); Day 37-38,41,44,47,50,54 (hr0);). 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.