NCT01450839

E2022 Patch Formulation Multiple Dose Study

E2022 Patch Formulation Multiple Dose Phase I Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the safety and tolerability of a E2022 16 mg tape when applied repeatedly for 17 days to healthy elderly Japanese male subjects, using E2022 placebo tape as the control.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	E2022	The treatment period consists of 2 periods, Period I and Period II. In Period I, one 5 mg E2020 tablet will be administered in a single dose. In Period II, the tape containing 16 mg E2022 (which corresponds to one 5 mg E2020 tablet) will be applied repeatedly for 17 days. A washout period of at least 8 days will be allowed between the day of single dose administration in Period I and the first day of repeated application in Period II. A post-treatment examination will be performed at least 21 days after the last removal of the investigational product in Period II.
DRUG	Placebo	Matching Placebo tablets and tape

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-11-01
• Completion: 2012-02-01
• First posted: 2011-10-12
• Last updated: 2012-06-01

Locations

1 site across 1 country: Japan