E2022 Patch Formulation Single Dose Phase I Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in healthy Japanese male volunteers.

Detailed Description
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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.

Official Title
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E2022 Patch Formulation Single Dose Phase I Study

Conditions
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Japanese Healthy Male Adult Volunteers

Intervention / Treatment
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* Drug: E2022
* Drug: E2022
* Drug: E2022
* Drug: E2022
* Drug: E2022


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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: 1<br> | Drug: E2022<br>* E2022 Type A patch<br>|
| Experimental: 2<br> | Drug: E2022<br>* E2022 Type B patch<br>|
| Experimental: 3<br> | Drug: E2022<br>* E2022 Type C patch<br>|
| Experimental: 4<br> | Drug: E2022<br>* E2022 Type D patch<br>|
| Experimental: 5<br> | Drug: E2022<br>* E2022 Type E patch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets. |  | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transdermal Administration