NCT02042729

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 39 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	E2022- 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.
DRUG	E2022- 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.
DRUG	E2022 Matching Placebo- Current Formula Tape
DRUG	E2022 Matching Placebo- New Formula Tape

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2014-01-23
• Last updated: 2014-02-21

Locations

1 site across 1 country: Japan