A Phase I Clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects

NCT01860625 | Completed Phase 1

• 1 other identifier: IPI-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in healthy male subjects.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• safety and tolerability evaluation

  evaluation item 1. adverse event 2. electrocardiographie 3. vital sign 4. physical examination 5. urine, blood test 6. skin irritation

  -1d~20d

Secondary Outcomes (1)

• pharmacokinetics characteristic evaluation

  1d 0h(before administration), (after administration)4h, 8h, 12h, 24h, 48h, 70h, 72h, 74h, 76h, 80h, 96h, 120h, 144h, 168h, 216h, 264h, 312h

Study Arms (3)

1(12.5㎠)

EXPERIMENTAL

drug : 9 people, 43.75mg/12.5㎠ placebo : 3 people, 12.5㎠

Drug: Donepezil patch; Drug: placebo

2(25㎠)

EXPERIMENTAL

drug : 9 people, 87.5mg/25㎠ placebo : 3 people, 25㎠

Drug: Donepezil patch; Drug: placebo

3(50㎠)

EXPERIMENTAL

drug : 9 people, 175mg/50㎠ placebo : 3 people, 50㎠

Drug: Donepezil patch; Drug: placebo

Interventions

Donepezil patch DRUG

1(12.5㎠); 2(25㎠); 3(50㎠)

placebo DRUG

1(12.5㎠); 2(25㎠); 3(50㎠)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI : more than 20 ㎏/㎡, less than 26 ㎏/㎡
• Systolic blood pressure : more than 90, less than 140 (mmHg)
• Diastolic blood pressure : more than 60, less than 100 (mmHg)

You may not qualify if:

• 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 caffeine intake(more than 5 units/day)
• 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.

Sponsors & Collaborators

• Icure Pharmaceutical Inc.: lead

Study Sites (1)

ASAN Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

• Choi HY, Kim YH, Hong D, Kim SS, Bae KS, Lim HS. Therapeutic dosage assessment based on population pharmacokinetics of a novel single-dose transdermal donepezil patch in healthy volunteers. Eur J Clin Pharmacol. 2015 Aug;71(8):967-77. doi: 10.1007/s00228-015-1875-2. Epub 2015 May 28.

  PMID: 26014587 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 23, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: June 30, 2014

Record last verified: 2014-06

Locations

KR (1)