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.

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: Donepezil; Drug: placebo

• Registration Number: NCT02178124
• Lead Sponsor: Icure Pharmaceutical Inc.

Brief Summary

Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch in healthy male subjects

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-06-30
• Study Start: 2014-07
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dosage 1	placebo	drug : 9 people(87.5mg/25cm2) placebo : 3 people(0mg/25cm2)
dosage 2	placebo	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)
dosage 1	Donepezil	drug : 9 people(87.5mg/25cm2) placebo : 3 people(0mg/25cm2)
dosage 2	Donepezil	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)

Primary Outcome Measures

Name	Time	Method
safety and tolerability evaluation	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

Secondary Outcome Measures

Name	Time	Method
pharmacokinetics characteristic evaluation	patch: -1~25d, oral -1~11d	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

Trial Locations

Locations (1)

ASAN Medical Center; 🇰🇷 Seoul, Korea, Republic of