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.

NCT02178124 | Completed Phase 1

• 1 other identifier: IPI-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Study of the Safety, tolerability and pharmacokinetics with multiple doses 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

  patch : -1d~33d, oral : -1~11d

Secondary Outcomes (1)

• pharmacokinetics characteristic evaluation

  patch: -1~25d, oral -1~11d

Study Arms (2)

dosage 1

EXPERIMENTAL

drug : 9 people(87.5mg/25cm2) placebo : 3 people(0mg/25cm2)

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)

Drug: Donepezil; Drug: placebo

Interventions

Donepezil DRUG

dosage 1; dosage 2

placebo DRUG

dosage 1; dosage 2

Eligibility Criteria

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

You may qualify if:

• 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)

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 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

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

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: June 27, 2014
• First Posted: June 30, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

KR (1)