Alzheimer DiseasePhase 1NCT02178124
A Phase I Clinical Study, Randomized, Single-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects.
A Phase 1 study testing Donepezil in people with Alzheimer Disease, run by Icure Pharmaceutical Inc. at 1 site in South Korea.
Trial summary
Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch in healthy male subjects Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Dec 2014
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI : more than 19 ㎏/㎡, less than 27 ㎏/㎡
- Systolic blood pressure : more than 90, less than 140 (mmHg)
- Diastolic blood pressure : more than 60, less than 100 (mmHg)
Who cannot join
- Evidence of clinically significant, severe, active, or unstable gastrointestinal, renal,hepatic, respiratory, hematological, endocrine, or cardiovascular system disease.
- A history of skin disease or skin graft
- Hypersensitivity to donepezil or piperidine derivatives or any of the excipients.
- A known or suspected history of drug or alcohol dependency or abuse
- Patients who have participated in another clinical study within 60 days.
- Whole blood within 60 days, apheresis within 30 days, transfusion within 30 days
Show all 10Show fewer
- Heavy alcohol intake(more than 21 units/week)
- Heavy smoker(more than 10 cigarette/day)
- Abnormal clinical laboratory values which are judged clinically significant by the investigator.
- Any condition that would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch in healthy male subjects
- Conditions
- Alzheimer Disease
- Being tested
- Donepezil, placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| dosage 1 | Experimental | drug : 9 people(87.5mg/25cm2) placebo : 3 people(0mg/25cm2) Receives: Drug: Donepezil; Drug: placebo |
| dosage 2 | Experimental | dosage2 period 1 : oral administration drug : 12 people(10mg)
dosage 2 period 2: transdermal administration drug : 9 people(175mg/50cm2) placebo : 3 people(0mg/50cm2) Receives: Drug: Donepezil; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability evaluation
evaluation item
- adverse event
- electrocardiographie
- vital sign
- physical examination
- urine, blood test
- skin irritation
Measured: patch : -1d~33d, oral : -1~11d
Secondary outcomes (1)
pharmacokinetics characteristic evaluation
cohort 1
1d 0h (pre-dose), 4h, 8h, 12h, 24h (2d), 48h (3d), 72h (4d), 144h (7d), 216h (10d), 288h (13d, last dose start), 292h, 296h, 300h, 312h (14d), 336h (15d), 360h (16d, patch removal), 362h, 364h, 368h, 372h, 384h (17d), 408h (18d), 432h (19d), 480h (21d), 528h (23d), 576h (25d)
cohort 2 1 period Oral Donepezil
1d 0h (pre-dose), 0.5h, 1h, 1.5h, 2h, 3h, 4h, 8h, 12h, 24h (2d), 48h (3d), 96h (5d), 144h (7d), 192h (9d), 240h (11d)
period 2 Donepezil Patch: same cohort1
evaluation item : donepezil conc.
evaluation variable patch : AUCτ,ss, Cmax,ss, t1/2β, AI (accumulation index), Cav,ss oral : AUClast, AUC0-∞, Cmax, tmax, t1/2β, CL/F
Measured: patch: -1~25d, oral -1~11d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icure Pharmaceutical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178124
- Sponsor's protocol ID
- IPI-002
- Status last verified
- Mar 2015
- First submitted
- 27 Jun 2014
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study, Randomized, Single-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects.
- ClinicalTrials.gov ID
- NCT02178124
- Acronym / sponsor ID
- IPI-002
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Icure Pharmaceutical Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Jun 2014 (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.
Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch in healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dosage 1 | Experimental | Drug: Donepezil, Drug: placebodrug : 9 people(87.5mg/25cm2) placebo : 3 people(0mg/25cm2) |
| dosage 2 | Experimental | Drug: Donepezil, Drug: placebodosage2 period 1 : oral administration drug : 12 people(10mg) dosage 2 period 2: transdermal administration drug : 9 people(175mg/50cm2) placebo : 3 people(0mg/50cm2) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI : more than 19 ㎏/㎡, less than 27 ㎏/㎡
- Systolic blood pressure : more than 90, less than 140 (mmHg)
- Diastolic blood pressure : more than 60, less than 100 (mmHg)
Key exclusion criteria (10 listed)
- Evidence of clinically significant, severe, active, or unstable gastrointestinal, renal,hepatic, respiratory, hematological, endocrine, or cardiovascular system disease.
- A history of skin disease or skin graft
- Hypersensitivity to donepezil or piperidine derivatives or any of the excipients.
- A known or suspected history of drug or alcohol dependency or abuse
- Patients who have participated in another clinical study within 60 days.
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 | Drug | dosage 1, dosage 2 |
| placebo | Drug | dosage 1, dosage 2 |
Primary outcome
safety and tolerability evaluation
Time frame: patch : -1d~33d, oral : -1~11d
evaluation item 1. adverse event 2. electrocardiographie 3. vital sign 4. physical examination 5. urine, blood test 6. skin irritation
1 secondary outcome
pharmacokinetics characteristic evaluation
Time frame: patch: -1~25d, oral -1~11d
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 25 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Alzheimer Disease, run by Icure Pharmaceutical Inc. at 1 site in South Korea.
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 3 inclusion and 10 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 25 Mar 2015. 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 South Korea. 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?
safety and tolerability evaluation (time frame: patch : -1d~33d, oral : -1~11d). 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 25 Mar 2015.