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

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety and pharmacokinetics of new patch formulation (tape) of E2022 by conducting patch test.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: E2022- Current Formula Tape
* Drug: E2022- New Formula Tape
* Drug: E2022 Matching Placebo- Current Formula Tape
* Drug: E2022 Matching Placebo- New Formula Tape


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E2022- Tape Formulation<br> | Drug: E2022- Current Formula Tape<br>* Cohort I: E2022 current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test. Cohort II: E2022 current formula tape administered to skin application site and evaluated for 20 days.<br>|
| Placebo Comparator: Matching Placebo E2022<br>Matching Placebo | Drug: E2022 Matching Placebo- Current Formula Tape<br> <br> * Other names: Cohort I: E2022 Matching Placebo current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.;|
| Active Comparator: E2022- New Formulation<br> | Drug: E2022- New Formula Tape<br>* Cohort I: E2022 new formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test. Cohort II: E2022 new formula tape administered to skin application site and evaluated for 20 days.<br>|
| Placebo Comparator: Placebo E2022- New Formulation<br>Matching Placebo | Drug: E2022 Matching Placebo- New Formula Tape<br> <br> * Other names: Cohort I: E2022 Matching Placebo new formula tape administered on a skin application site and evaluated for;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | 10 days (Cohort I) and 40 days (Cohort II) | 
| Frequency of Adverse Events |  | 10 days (Cohort I) and 40 days (Cohort II) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Parameter: Cmax |  | 40 days (Cohort II) | 
| Pharmacokinetic Parameter: Tmax |  | 40 days (Cohort II) | 
| Pharmacokinetic Parameter: AUC |  | 40 days (Cohort II) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volunteer