Back to resultsA 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.
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Donepezil
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- ASAN Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
dosage 1
dosage 2
Arm Description
drug : 9 people(87.5mg/25cm2) placebo : 3 people(0mg/25cm2)
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)
Outcomes
Primary Outcome Measures
safety and tolerability evaluation
evaluation item
adverse event
electrocardiographie
vital sign
physical examination
urine, blood test
skin irritation
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02178124
First Posted
June 27, 2014
Last Updated
March 23, 2015
Sponsor
Icure Pharmaceutical Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02178124
Brief 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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icure Pharmaceutical Inc.
4. Oversight
5. Study Description
Brief Summary
Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch in healthy male subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dosage 1
Arm Type
Experimental
Arm Description
drug : 9 people(87.5mg/25cm2) placebo : 3 people(0mg/25cm2)
Arm Title
dosage 2
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Donepezil
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
safety and tolerability evaluation
Description
evaluation item
adverse event
electrocardiographie
vital sign
physical examination
urine, blood test
skin irritation
Time Frame
patch : -1d~33d, oral : -1~11d
Secondary Outcome Measure Information:
Title
pharmacokinetics characteristic evaluation
Description
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
Time Frame
patch: -1~25d, oral -1~11d
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
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.
Facility Information:
Facility Name
ASAN Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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.
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