A Phase 1 Comparative Study of E2022 Current and New Patch Formulations

Inclusion criteria

• Non-smoker or not smoking for 4 weeks or longer before study treatment
• BMI at screening is greater than or equal to 18.5 kg/m2 or less than 25.0 kg/m2
• With written informed consent
• Given full explanation of this study and is willing to and able to comply with study requirements.

Exclusion criteria

(Cohort 1 and 2):

• Have a disorder 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 clinically significant abnormality or organ dysfunction
• Have a history of allergy to drug or food requiring medical treatment or seasonal allergy at screening
• Have a history or complication of contact dermatitis or atopic dermatitis
• Have hairy back or have shaved within 4 weeks before study treatment
• Have a skin disease (e.g., eczema, dermatitis, dyschromatosis), or skin damage (e.g., injury, scar, or sun burn) which may affect skin assessment
• Have a history or suspected to have drug or alcohol dependence, or positive for urine drug screen at baseline or a day before screening
• Have had caffeine-containing drink or food, or alcohol within 72 hours before study treatment
• Have used liquid product (including cosmetics), or applied patch, tape, or bandage on the back within 4 weeks before study treatment
• Had hard exercise at least 5 days a week or a 1-hour or longer hard exercise within 2 weeks before study treatment

(Only Cohort 2):

• Meet QTc of greater than 450 milliseconds at screening or immediately before study treatment
• Had nutrients, herb preparations (e.g. oriental medicine), other food or drink (e.g., grapefruit-containing juice) which may affect the activity of drug-metabolizing enzyme or transporter within 2 weeks before study treatment
• Had St. John's Wort-containing preparation within 4 weeks before Period 1 application