E2022 Patch Formulation Single Dose Phase I Study

The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in healthy Japanese male volunteers.

Study Overview

• Status: Completed
• Conditions: Japanese Healthy Male Adult Volunteers
• Intervention / Treatment: Drug: E2022; Drug: E2022; Drug: E2022; Drug: E2022; Drug: E2022

Detailed Description

This study is an open-label single site, randomized single dose study in 80 healthy Japanese male volunteers. The study consists of Period I to Period III, a total of 3 periods. In Period I, E2022 patches will be secured with seal. In Period II, single dose of E2022 5 mg tablet will be administered. In Period III, E2022 patches will be applied without seal. The features of the 5 patches will be evaluated in this study.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kagoshima, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria

1. Body Mass Index (BMI) at Screening is 18.5 kg/m2 or above and less than 25.0 kg/m2: BMI (kg/m2)= weight(kg) ÷ {height(m)× height(m)}
2. Subjects who are between 20 and 55 years of age at the time of obtaining written consent.
3. Subjects who are willing to and can comply with the conditions described in the study protocol.

Exclusion Criteria

1. Subjects who consumed caffeine-containing food or beverages within 72 hours before study drug administration.
2. Exposure to any supplements or herbs (including Chinese medicine), or beverages (e.g. alcohol or grapefruit-containing beverages) known to modulate CYP3A4, CYP2C9, CYP2C19, CYP2D6, within 2 weeks before study drug administration.
3. Subjects with history of cutaneous hypersensitivity to external preparation, or those who are on another transdermal formulation.
4. Subjects who have excessive skin hair around the region to put the patch on.
5. Subjects with skin disorder, such as eczema, skin irritation, pigment disorder, injury or scar in the region of patch application, which may have an impact on skin findings.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: E2022; E2022 Type A patch; Drug: E2022; E2022 Type B patch; Drug: E2022; E2022 Type C patch; Drug: E2022; E2022 Type D patch; Drug: E2022; E2022 Type E patch
Experimental: 2	Drug: E2022; E2022 Type A patch; Drug: E2022; E2022 Type B patch; Drug: E2022; E2022 Type C patch; Drug: E2022; E2022 Type D patch; Drug: E2022; E2022 Type E patch
Experimental: 3	Drug: E2022; E2022 Type A patch; Drug: E2022; E2022 Type B patch; Drug: E2022; E2022 Type C patch; Drug: E2022; E2022 Type D patch; Drug: E2022; E2022 Type E patch
Experimental: 4	Drug: E2022; E2022 Type A patch; Drug: E2022; E2022 Type B patch; Drug: E2022; E2022 Type C patch; Drug: E2022; E2022 Type D patch; Drug: E2022; E2022 Type E patch
Experimental: 5	Drug: E2022; E2022 Type A patch; Drug: E2022; E2022 Type B patch; Drug: E2022; E2022 Type C patch; Drug: E2022; E2022 Type D patch; Drug: E2022; E2022 Type E patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets.	15 days

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.
• Investigators: Study Director: Tomoo Ogawa, Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: November 30, 2010
• First Submitted That Met QC Criteria: December 2, 2010
• First Posted (Estimate): December 3, 2010

Study Record Updates

• Last Update Posted (Estimate): May 14, 2013
• Last Update Submitted That Met QC Criteria: May 13, 2013
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Transdermal Administration
• Other Study ID Numbers: E2022-J081-001