A Study of E2022 Tape Formulation (Overlay-integrated E2022 18 mg Tape Formulation) for Different Application Sites and Intervals in Japanese Healthy Elderly Males

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).

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