E2022 Patch Formulation Single Dose Phase I Study

This study is an open-label single site, randomized single dose study in 80 healthy Japanese male volunteers. The study consists of Period I to Period III, a total of 3 periods. In Period I, E2022 patches will be secured with seal. In Period II, single dose of E2022 5 mg tablet will be administered. In Period III, E2022 patches will be applied without seal. The features of the 5 patches will be evaluated in this study.

Inclusion criteria

• Body Mass Index (BMI) at Screening is 18.5 kg/m2 or above and less than 25.0 kg/m2: BMI (kg/m2)= weight(kg) ÷ {height(m)× height(m)}
• Subjects who are between 20 and 55 years of age at the time of obtaining written consent.
• Subjects who are willing to and can comply with the conditions described in the study protocol.

Exclusion criteria

• Subjects who consumed caffeine-containing food or beverages within 72 hours before study drug administration.
• Exposure to any supplements or herbs (including Chinese medicine), or beverages (e.g. alcohol or grapefruit-containing beverages) known to modulate CYP3A4, CYP2C9, CYP2C19, CYP2D6, within 2 weeks before study drug administration.
• Subjects with history of cutaneous hypersensitivity to external preparation, or those who are on another transdermal formulation.
• Subjects who have excessive skin hair around the region to put the patch on.
• Subjects with skin disorder, such as eczema, skin irritation, pigment disorder, injury or scar in the region of patch application, which may have an impact on skin findings.