E2022 Patch Formulation Single Dose Phase I Study

Japanese Healthy Male Adult Volunteers Clinical Trial

Official title:

E2022 Patch Formulation Single Dose Phase I Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253434
• Other study ID #: E2022-J081-001
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2010
• Last updated: May 13, 2013
• Start date: November 2010
• Est. completion date: March 2011

Study information

• Verified date: August 2011
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Japanese Healthy Male Adult Volunteers

Intervention

Drug:
• E2022
E2022 Type A patch
• E2022
E2022 Type B patch
• E2022
E2022 Type C patch
• E2022
E2022 Type D patch
• E2022
E2022 Type E patch

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets.		15 days	No