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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2022- Tape Formulation | Experimental |
| |
| Matching Placebo E2022 | Placebo Comparator | Matching Placebo |
|
| E2022- New Formulation | Active Comparator |
| |
| Placebo E2022- New Formulation | Placebo Comparator | Matching Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2022- Current Formula Tape | Drug | 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter: Cmax | 40 days (Cohort II) | |
| Pharmacokinetic Parameter: Tmax | 40 days (Cohort II) | |
| Pharmacokinetic Parameter: AUC |
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Inclusion criteria
Exclusion criteria
(Cohort 1 and 2):
(Only Cohort 2):
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| Name | Affiliation | Role |
|---|---|---|
| Hidetaka Hiramatsu | Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Fukuoka | Japan |
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|
| E2022- New Formula Tape | Drug | 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. |
|
| E2022 Matching Placebo- Current Formula Tape | Drug |
|
|
| E2022 Matching Placebo- New Formula Tape | Drug |
|
|
| 40 days (Cohort II) |