E2022 Patch Formulation Multiple Dose Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: E2022; Drug: Placebo

• Registration Number: NCT01450839
• Lead Sponsor: Eisai Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-12
• Primary Completion: 2011-11
• Study Completion: 2012-02
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-30
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
E2020 5 mg tablet and tape	E2022	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Composite (or Profile) of Pharmacokinetics	predose, 0,1, 2, 3, 4, 6, 8,1 2, 24, 48, 72, 96 hours post-dose	Cmax, Area Under Curve, Tmax