E2022 Patch Formulation Multiple Dose Study

Inclusion criteria

• Subjects who are non-smoking males (not smoking for at least 4 weeks before the administration of the investigational product in Period I) 65 years or older at the time of giving informed consent
• Subjects whose body mass index (BMI) is 18.5 kg/m^2 to less than 28.0 kg/m^2 at the screening
• Subjects who give voluntary written consent to participate in the study
• Subjects who have been fully informed of matters subjects are required to observe during the study and can, and are willing to, comply with the rules.

Exclusion criteria

• Subjects with a history of treatment-requiring disease within 8 weeks before administration of the investigational product in Period I or history of infection within 4 weeks before administration of the investigational product in Period I
• Subjects who have, within 4 weeks before administration of the investigational product in Period I, a disease that might affect the evaluation of the investigational product, such as mental, gastrointestinal, hepatic, renal, respiratory, endocrine, hematological, nervous, or cardiovascular diseases, and inborn error of metabolism
• Subjects with a history of surgical treatment of the gastrointestinal tract (e.g., resection of the liver, kidney, gastrointestinal tract, etc.) that may affect the pharmacokinetics of the investigational product
• Subjects with a history of treatment-requiring drug or food allergy or with seasonal allergy at the screening
• Subjects with a change in body weight of more than 10% at 1 day before investigational product administration in Period I, compared with that observed at the screening
• Subjects with clinically significant, treatment-requiring symptoms or impairment of organ function, judging from the subjective symptoms/objective findings, vital signs, 12-lead ECG, or laboratory test performed during the period from the screening to immediately before investigational product administration in Period I
• Subjects with QTc>450 ms on 12-lead ECG performed at the screening or immediately before investigational product administration in Period I
• Subjects who are positive for human immunodeficiency virus (HIV) antibody, hepatitis B virus surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, or qualitative syphilis test, at the screening
• Subjects with a history of, or suspected diagnosis of, drug or alcohol dependence or Subjects who are positive for urine drug test at the screening or 1 day before investigational product administration in Period I
• Subjects who took caffeine-containing or alcoholic beverage within 72 hours before investigational product administration in Period I
• Subjects who took, within 2 weeks before investigational product administration in Period I, nutritional supplements, herb-containing drug preparations (including Chinese medicines) or other foods or beverages (e.g., grapefruit-containing foods or beverages) that may affect drug-metabolizing enzymes or transporters
• Subjects who took drug preparations containing St. John's wort within 4 weeks before investigational product administration in Period I
• Subjects who took prescription drugs within 4 weeks before investigational product administration in Period I
• Subjects who took non-prescription drugs within 2 weeks before investigational product administration in Period I
• Subjects who participated in another clinical study within 16 weeks before investigational product administration in Period I and used an investigational product or medical device
• Subjects who received blood transfusion within 12 weeks, had 400 mL or more whole blood collected within 12 weeks, had 200 mL or more whole blood collected within 4 weeks, or donated blood components within 2 weeks, before investigational product administration in Period I
• Subjects who performed strenuous exercise at a frequency of 5 days or more per week or who performed, even once, a strenuous exercise lasting 1 hour or more, within 2 weeks before admission for Period I
• Subjects with past or current clinical signs of cutaneous hypersensitivity or atopic dermatitis to external medicines
• Subjects in whom the investigational product and the fixing sheet cannot be applied to 6 or more non-overlapping sites on the back (except the vertebral region and the site around the angulus inferior scapulae) by rotation method
• Subjects with excessive hair at the application site (back)
• Subjects with conditions at the application site (back), such as skin diseases (e.g., eczema, dermatitis and pigmentary abnormality), external injuries, and scars, that may affect the evaluation of skin symptom
• Subjects who, or whose partners, are not willing to take reliable contraceptive measures until the completion of the post-treatment examination
• Subjects who are judged by the investigator or subinvestigator to be inappropriate as subjects of the study