Healthy
Conditions
Keywords
volunteer
Brief summary
The purpose of this study is to investigate the safety and pharmacokinetics of new patch formulation (tape) of E2022 by conducting patch test.
Interventions
DRUGE2022- Current Formula Tape
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.
DRUGE2022- New Formula Tape
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.
DRUGE2022 Matching Placebo- Current Formula Tape
DRUGE2022 Matching Placebo- New Formula Tape
Sponsors
Eisai Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
1. Non-smoker or not smoking for 4 weeks or longer before study treatment 2. BMI at screening is greater than or equal to 18.5 kg/m2 or less than 25.0 kg/m2 3. With written informed consent 4. Given full explanation of this study and is willing to and able to comply with study requirements.
Exclusion criteria
(Cohort 1 and 2): 1. 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 2. Have a clinically significant abnormality or organ dysfunction 3. Have a history of allergy to drug or food requiring medical treatment or seasonal allergy at screening 4. Have a history or complication of contact dermatitis or atopic dermatitis 5. Have hairy back or have shaved within 4 weeks before study treatment 6. Have a skin disease (e.g., eczema, dermatitis, dyschromatosis), or skin damage (e.g., injury, scar, or sun burn) which may affect skin assessment 7. Have a history or suspected to have drug or alcohol dependence, or positive for urine drug screen at baseline or a day before screening 8. Have had caffeine-containing drink or food, or alcohol within 72 hours before study treatment 9. Have used liquid product (including cosmetics), or applied patch, tape, or bandage on the back within 4 weeks before study treatment 10. 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): 1. Meet QTc of greater than 450 milliseconds at screening or immediately before study treatment 2. 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 3. Had St. John's Wort-containing preparation within 4 weeks before Period 1 application
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Pharmacokinetic Parameter: Cmax | 40 days (Cohort II) |
| Pharmacokinetic Parameter: Tmax | 40 days (Cohort II) |
| Pharmacokinetic Parameter: AUC | 40 days (Cohort II) |
Countries
Japan
Outcome results
None listed