A Phase 1 Study of E2022 Tape Formulation for Different Application Sites and Intervals in Japanese Healthy Elderly Males

Study Overview
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Brief Summary
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A phase 1 study of E2022 tape formulation in healthy elderly males to evaluate the safety and pharmacokinetics.

Official Title
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A Phase 1 Study of E2022 Tape Formulation for Different Application Sites and Intervals

Conditions
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Healthy Elderly Male

Intervention / Treatment
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* Drug: E2022 Tape Formulation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male non-smokers (not smoking at least 4 weeks before Period 1) aged 65 years or older at informed consent BMI at screening is 18.5 kg/m2 or above - below 28.0 kg/m2 Written informed consent Given full explanation of this study and is willing to and able to comply with the protocol requirements Exclusion criteria: Have a current or past history of disorder requiring medical treatment within 8 weeks before the first application or infection within 4 weeks before the first application Have a disorder within 4 weeks before the first application which affects the evaluation of study drug such as psychiatric, gastrointestinal, hepatic, renal, respiratory, endocrinological, hematological, neurological or cardiovascular system, or congenital metabolic abnormality Have a history of gastrointestinal surgery (e.g., liver, kidney, digestive tract) which affects the pharmacokinetics of study drug, Have a history of treatment-requiring drug or food allergy or seasonal allergy at screening Had caffeine-containing food or drink or alcohol within 72 hours before study drug application in Period I Had nutritional supplements, herbal preparations (including oriental medicines) or others (e.g., grapefruit-containing food or beverage) which may affect drug metabolizing enzymes and transporters, within 1 weeks before Period I Have used liquid products (including cosmetics) on study application sites (back, upper limb, chest), patch, tape or bandage, within 4 weeks before Period 1 Present or past clinical signs of skin hypersensitivity to topical product or atopic dermatitis Excessively hairy or have shaved at application sites (back, upper limb, chest) within 4 weeks before Period 1 Eczema, dermatitis, abnormal pigmentation, injury, or scar at application sites which may affect the evaluation of skin symptoms

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E2022 Tape Formulation<br> | Drug: E2022 Tape Formulation<br>* E2022 tape formulation applied to different application sites and at different intervals in Japanese healthy elderly males<br>* Other names: Donepezil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and frequency of adverse events |  | 168 hours after the end of application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Drug Concentration (CMax) |  | 216 hours after the end of application | 
| Area Under the Plasma Concentration-Time Curve (AUC) |  | 216 hours after the end of application | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 216 hours after the end of application | 
| Plasma Decay Half-Life (t1/2) |  | 216 hours after the end of application |