Alzheimer's DiseasePhase 1NCT03438604
A Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil Transdermal Delivery System (TDS)
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 study to assess the effect of heat application on the delivery profile of Corplex™ Donepezil Transdermal Delivery System (TDS) 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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2018to 30 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 ≥ 30 years of age
Who cannot join
- History of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the subject by participation in the study
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first study product treatment
- History or presence of hypersensitivity or idiosyncratic reaction to the study products or related compounds
- History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs
- History or presence of excessive sweating
- History or presence of hairy skin on application sites
- History or presence of significant skin damage or disease at application sites
- Any medical or surgical procedure or trauma within 28 days prior to the first study product treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, 2-Way Crossover Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil 5 mg Transdermal Delivery System (TDS) in Healthy Volunteers
A study to assess the effect of heat application on the delivery profile of Corplex™ Donepezil Transdermal Delivery System (TDS)
Read the detailed description
2-Way Crossover study
Approximately 24 healthy, adult male and female subjects will be enrolled.
Subjects will be randomized to 1 of 2 treatment sequences prior to the first TDS application in treatment period 1.
For each treatment period, subjects will have one 7-day TDS applied on their back. Depending on which sequence a subject is randomized to, the healthy subject will either be exposed to heat or not during the TDS wear time.
Blood samples for Donepezil PK will be collected pre-dose until the end of each treatment period.
Adhesion will be monitored throughout the TDS wear time, and skin irritation will be monitored after TDS removal.
Subjects who complete the 2-way crossover study may be eligible to participate in the optional Study Extension Period. In the Study Extension Period, subjects will have their skin surface temperature monitored under the patch and adjacent to the TDS.
Blood samples for Donepezil PK will not be collected, and adhesion will not be monitored for the Study Extension TDS wear period.
Safety will be monitored throughout the study by adverse event reporting and 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 with Heat Applied | Other | Corplex Donepezil TDS 5 mg/day with heat applied Receives: Drug: Donepezil TDS |
| Donepezil TDS without Heat | Other | Corplex Donepezil TDS 5 mg/day with no heat applied Receives: Drug: Donepezil TDS |
| Donepezil TDS Extension Study with Heat | Other | Corplex Donepezil TDS 5 mg/day with heat. Two skin sensors will be placed underneath the TDS and adjacent to the TDS. Receives: Drug: Donepezil TDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics, Cmax
Peak plasma concentration (Cmax) of once-weekly Donepezil TDS in the presence and absence of heat
Measured: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total
Pharmacokinetics, AUC
Area under the curve (AUC) of once-weekly Donepezil TDS in the presence and absence of heat
Measured: Blood samples for the Donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 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 and during the 5 week follow-on period
Summary Listing of Skin Irritation Score of Donepezil 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 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 the presence and absence of heat
Measured: 0.5 hr, 24 hr, 48 hr, 72 hr after each TDS removal (3 days)
Application Site Mean Adhesion Scores of Donepezil TDS
Adhesion data will be collected during each 7-day patch wear period
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 posted19 Feb 2018
- Study start13 Feb 2018
- Primary completion19 Jun 2018
- Study completion30 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
- 24 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
- NCT03438604
- Sponsor's protocol ID
- P-16039
- Status last verified
- Sep 2018
- First submitted
- 13 Feb 2018
- Last updated
- 14 Sep 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 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 2-Way Crossover Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil 5 mg Transdermal Delivery System (TDS) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03438604
- Acronym / sponsor ID
- P-16039
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Corium, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 19 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 19 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 study to assess the effect of heat application on the delivery profile of Corplex™ Donepezil Transdermal Delivery System (TDS)
Detailed description
2-Way Crossover study
Approximately 24 healthy, adult male and female subjects will be enrolled.
Subjects will be randomized to 1 of 2 treatment sequences prior to the first TDS application in treatment period 1.
For each treatment period, subjects will have one 7-day TDS applied on their back. Depending on which sequence a subject is randomized to, the healthy subject will either be exposed to heat or not during the TDS wear time.
Blood samples for Donepezil PK will be collected pre-dose until the end of each treatment period.
Adhesion will be monitored throughout the TDS wear time, and skin irritation will be monitored after TDS removal.
Subjects who complete the 2-way crossover study may be eligible to participate in the optional Study Extension Period. In the Study Extension Period, subjects will have their skin surface temperature monitored under the patch and adjacent to the TDS.
Blood samples for Donepezil PK will not be collected, and adhesion will not be monitored for the Study Extension TDS wear period.
Safety will be monitored throughout the study by adverse event reporting and 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 with Heat Applied | Other | Drug: Donepezil TDSCorplex Donepezil TDS 5 mg/day with heat applied |
| Donepezil TDS without Heat | Other | Drug: Donepezil TDSCorplex Donepezil TDS 5 mg/day with no heat applied |
| Donepezil TDS Extension Study with Heat | Other | Drug: Donepezil TDSCorplex Donepezil TDS 5 mg/day with heat. Two skin sensors will be placed underneath the TDS and adjacent to the TDS. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, adult, male or female ≥ 30 years of age
Key exclusion criteria (8 listed)
- History of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the subject by participation in the study
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first study product treatment
- History or presence of hypersensitivity or idiosyncratic reaction to the study products or related compounds
- History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs
- History or presence of excessive sweating
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 Extension Study with Heat, Donepezil TDS with Heat Applied, Donepezil TDS without Heat |
Primary outcome
Pharmacokinetics, Cmax
Time frame: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total
Peak plasma concentration (Cmax) of once-weekly Donepezil TDS in the presence and absence of heat
Pharmacokinetics, AUC
Time frame: Blood samples for the Donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total
Area under the curve (AUC) of once-weekly Donepezil TDS in the presence and absence of heat
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 and during the 5 week follow-on period
Summary Listing of Skin Irritation Score of Donepezil TDS by post-removal time point
Time frame: 0.5 hr, 24 hr, 48 hr, 72 hr after each TDS removal (3 days)
Application Site Mean Adhesion Scores of Donepezil 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 14 Sep 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 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 1 inclusion and 8 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 14 Sep 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, Cmax (time frame: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 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 14 Sep 2018.