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E2022 Patch Formulation Multiple Dose Study

NCT01450839 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2012-06-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hidetaka Hiramatsu · Neuroscience Cliical Development Section, Japan /Asia Clinical Research PCU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-11-30
Completion
2012-02-29

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01450839 on ClinicalTrials.gov