Alzheimer's DiseasePhase 1NCT03432195
A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations
A Phase 1 study testing Donepezil TDS in people with Alzheimer's Disease, run by Corium, Inc. at 1 site in United States.
Trial summary
A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 28 Jun 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
- 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
- Hemoglobin value of less than 11.5 g/dl for females, 13.0 g/dl for males at screening and first check-in
- Muscle relaxants, anti-Parkinsonian or neuroleptic medications prior to the first dose of study drug
Show all 9Show fewer
- History or presence of significant skin damage or other skin disturbances as deemed by the Investigator to potentially interfere with patch procedures
- Use of donepezil hydrochloride or related drugs 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: A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations
A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations
Read the detailed description
Randomized, open-label, 3-way crossover study
Up to 66 healthy, adult male and female subjects will be enrolled.
All subjects will receive Corplex Donepezil TDS patches applied to 3 different locations on each subject (back, buttock, and leg) during 3 different, consecutive treatment periods. For each subject, the location of product administration during each treatment period will be randomized.
During each treatment period, all subjects will receive a once-weekly 10 mg TDS, target dose 10 mg donepezil/day, applied for 7 days (1 week) on either the back, buttock, or leg in accordance with the randomized treatment location for that treatment period.
Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period. The PK sample collection time points are as follows:
Week 1: Pre-TDS application prior to 0 hour and post-TDS application at 2, 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 hours.
Week 2: Pre-Week 1 TDS removal at 168 hours, and post-TDS removal at up to 528 hours
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
- 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
| Study group | Role | What they receive |
|---|---|---|
| Donepezil TDS Back | Experimental | Corplex Donepezil TDS 10 mg/day applied to the Back for 1 week (7 days) Receives: Drug: Donepezil TDS |
| Donepezil TDS Buttock | Experimental | Corplex Donepezil TDS 10 mg/day applied to the Buttock for 1 week (7 days) Receives: Drug: Donepezil TDS |
| Donepezil TDS Leg | Experimental | Corplex Donepezil TDS 10 mg/day applied to the Leg for 1 week (7 days) Receives: Drug: Donepezil TDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics, AUC
Area under the plasma concentration versus time curve (AUC) of once-weekly Corplex Donepezil TDS applied to different body locations.
Measured: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total
Pharmacokinetics, CMAX
Peak Plasma Concentration (Cmax) of once-weekly Corplex Donepezil TDS applied to different body locations.
Measured: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total
Secondary outcomes (3)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
General Safety (adverse events and serious adverse events as reported by subject following guidance CTCAE v4.0)
Measured: Daily during 1 week treatment period throughout the 5 week period
Summary Listing of Skin Irritation Score of Donepezil Corplex TDS by post-removal time point
Skin irritation score is determined by the sum of Dermal Response score (8-point categorical scale; where 0=no evidence of irritation to 7=strong reaction) using numeric values) and the Other Effects score (6-point categorical scale where 0=none observed to H=scabs/erosion using alphabet letters equivalent to numeric values) and summarized by application site (back, buttock and leg)
Measured: 0.5hr, 24hr, 48hr and 72hr after each TDS removal. (3 days)
Application Site Mean Adhesion Scores of Donepezil Corplex TDS
Adhesion score is collected using a 12-point categorical scale, where 0=100% adhered to 11=detached
Measured: Daily during 1 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 posted14 Feb 2018
- Study start31 Jan 2018
- Primary completion28 Jun 2018
- Study completion28 Jun 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corium, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danielle Armas, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432195
- Sponsor's protocol ID
- P16012
- Status last verified
- Aug 2018
- First submitted
- 31 Jan 2018
- Last updated
- 7 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 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations
- ClinicalTrials.gov ID
- NCT03432195
- Acronym / sponsor ID
- P16012
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Corium, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 14 Feb 2018 (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 Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations
Detailed description
Randomized, open-label, 3-way crossover study
Up to 66 healthy, adult male and female subjects will be enrolled.
All subjects will receive Corplex Donepezil TDS patches applied to 3 different locations on each subject (back, buttock, and leg) during 3 different, consecutive treatment periods. For each subject, the location of product administration during each treatment period will be randomized.
During each treatment period, all subjects will receive a once-weekly 10 mg TDS, target dose 10 mg donepezil/day, applied for 7 days (1 week) on either the back, buttock, or leg in accordance with the randomized treatment location for that treatment period.
Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period. The PK sample collection time points are as follows:
Week 1: Pre-TDS application prior to 0 hour and post-TDS application at 2, 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 hours.
Week 2: Pre-Week 1 TDS removal at 168 hours, and post-TDS removal at up to 528 hours
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
- 3
| Arm | Type | Receives |
|---|---|---|
| Donepezil TDS Back | Experimental | Drug: Donepezil TDSCorplex Donepezil TDS 10 mg/day applied to the Back for 1 week (7 days) |
| Donepezil TDS Buttock | Experimental | Drug: Donepezil TDSCorplex Donepezil TDS 10 mg/day applied to the Buttock for 1 week (7 days) |
| Donepezil TDS Leg | Experimental | Drug: Donepezil TDSCorplex Donepezil TDS 10 mg/day applied to the Leg for 1 week (7 days) |
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 (9 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
- 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
- Hemoglobin value of less than 11.5 g/dl for females, 13.0 g/dl for males at screening and first check-in
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 Back, Donepezil TDS Buttock, Donepezil TDS Leg |
Primary outcome
Pharmacokinetics, AUC
Time frame: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total
Area under the plasma concentration versus time curve (AUC) of once-weekly Corplex Donepezil TDS applied to different body locations.
Pharmacokinetics, CMAX
Time frame: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total
Peak Plasma Concentration (Cmax) of once-weekly Corplex Donepezil TDS applied to different body locations.
3 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Daily during 1 week treatment period throughout the 5 week period
Summary Listing of Skin Irritation Score of Donepezil Corplex TDS by post-removal time point
Time frame: 0.5hr, 24hr, 48hr and 72hr after each TDS removal. (3 days)
Application Site Mean Adhesion Scores of Donepezil Corplex TDS
Time frame: Daily during 1 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 7 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 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 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 9 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 7 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?
Pharmacokinetics, AUC (time frame: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 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 7 Aug 2018.