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.

Alzheimer Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178124
• Other study ID #: IPI-002
• Status: Completed
• Phase: Phase 1
• First received: June 27, 2014
• Last updated: March 23, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Icure Pharmaceutical Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Donepezil

• placebo

Locations

Country	Name	City	State
Korea, Republic of	ASAN Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Icure Pharmaceutical Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerability evaluation	evaluation item; adverse event; electrocardiographie; vital sign; physical examination; urine, blood test; skin irritation	patch : -1d~33d, oral : -1~11d	No
Secondary	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 : AUCt,ss, Cmax,ss, t1/2ß, AI (accumulation index), Cav,ss oral : AUClast, AUC0-8, Cmax, tmax, t1/2ß, CL/F	patch: -1~25d, oral -1~11d	No