A Study of E2022 Tape Formulation (Overlay-integrated E2022 18 mg 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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This is a single-center, 4-group, open-label study in Japanese healthy elderly males. A total of 48 subjects will be randomized to one of four groups (A to D, 12 subjects/group) to administer one E2022 tape to designated sites.

Detailed Description
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This study consists of Screening, Treatment Period, and Follow-up. The Treatment Period is subdivided into three periods (Periods 1 to 3). Screening will start within 4 weeks before starting Treatment Period 1. In Treatment Periods 1 and 2, one E2022 tape will be applied to the designated site. The Treatment Period 2 application must have at least a 17-day interval from the end of Treatment Period 1 application. In Treatment Period 3, E2022 tape will be applied to back site (contralateral to the first applied site during Treatment Periods 1 and 2) after at least 17 days from the end of Treatment Period 2 (removing). A new E2022 tape will be applied to the same site after the specified intervals from the end of previous application (removing) in each group. Follow-up will start after at least a 17-day interval from the end of re-application in the Treatment Period 3 (removing).

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: E2022


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 1 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 week before Period 1 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Period 1: Apply one E2022 tape to the designated site (back or upper arm) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or upper arm, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group A: 48 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning]) | Drug: E2022<br>* transdermal E2022 tape formulation (8.1 cm x 8.1 cm)<br>|
| Experimental: Group B<br>Period 1: Apply one E2022 tape to the designated site (back or upper arm) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or upper arm, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group B: 72 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning]) | Drug: E2022<br>* transdermal E2022 tape formulation (8.1 cm x 8.1 cm)<br>|
| Experimental: Group C<br>Period 1: Apply one E2022 tape to the designated site (back or chest) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or chest, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group C: 96 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning]) | Drug: E2022<br>* transdermal E2022 tape formulation (8.1 cm x 8.1 cm)<br>|
| Experimental: Group D<br>Period 1: Apply one E2022 tape to the designated site (back or chest) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or chest, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group D: 120 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning]) | Drug: E2022<br>* transdermal E2022 tape formulation (8.1 cm x 8.1 cm)<br>|

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 |
| --- | --- | --- |
| Pharmacokinetics of E2022: Cmax | Maximal Drug Concentration (Cmax) | 216 hours after the end of application | 
| Pharmacokinetics of E2022: AUC | Area Under the Plasma Concentration-Time Curve (AUC) | 216 hours after the end of application | 
| Pharmacokinetics of E2022: Tmax | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 216 hours after the end of application | 
| Pharmacokinetics of E2022: t1/2 | Plasma Decay Half-Life (t1/2) | 216 hours after the end of application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Subjects, Japanese, Males