NCT02225288

A Study of E2022 Tape Formulation (Overlay-integrated E2022 18 mg Tape Formulation) for Different Application Sites and Intervals in Japanese Healthy Elderly Males

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, 4-group, open-label study in Japanese healthy elderly males. A total of 48 subjects will be randomized to one of four groups (A to D, 12 subjects/group) to administer one E2022 tape to designated sites.

Detailed description

This study consists of Screening, Treatment Period, and Follow-up. The Treatment Period is subdivided into three periods (Periods 1 to 3). Screening will start within 4 weeks before starting Treatment Period 1. In Treatment Periods 1 and 2, one E2022 tape will be applied to the designated site. The Treatment Period 2 application must have at least a 17-day interval from the end of Treatment Period 1 application. In Treatment Period 3, E2022 tape will be applied to back site (contralateral to the first applied site during Treatment Periods 1 and 2) after at least 17 days from the end of Treatment Period 2 (removing). A new E2022 tape will be applied to the same site after the specified intervals from the end of previous application (removing) in each group. Follow-up will start after at least a 17-day interval from the end of re-application in the Treatment Period 3 (removing).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	E2022	transdermal E2022 tape formulation (8.1 cm x 8.1 cm)

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-12-01
• Completion: 2015-02-01
• First posted: 2014-08-26
• Last updated: 2015-04-02

Locations

1 site across 1 country: Japan