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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: E2022- Current Formula Tape; Drug: E2022 Matching Placebo- Current Formula Tape; Drug: E2022- New Formula Tape; Drug: E2022 Matching Placebo- New Formula Tape

• Registration Number: NCT02042729
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-23
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-20
• Last Update Posted: 2014-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
E2022- Tape Formulation	E2022- Current Formula Tape	-
Matching Placebo E2022	E2022 Matching Placebo- Current Formula Tape	Matching Placebo
E2022- New Formulation	E2022- New Formula Tape	-
Placebo E2022- New Formulation	E2022 Matching Placebo- New Formula Tape	Matching Placebo

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Parameter: Tmax	40 days (Cohort II)
Pharmacokinetic Parameter: AUC	40 days (Cohort II)
Pharmacokinetic Parameter: Cmax	40 days (Cohort II)