E2022 Patch Formulation Single Dose Phase I Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01253434
First received: November 30, 2010
Last updated: May 13, 2013
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Japanese Healthy Male Adult Volunteers
Drug: E2022
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: E2022 Patch Formulation Single Dose Phase I Study

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets. [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E2022
E2022 Type A patch
Experimental: 2 Drug: E2022
E2022 Type B patch
Experimental: 3 Drug: E2022
E2022 Type C patch
Experimental: 4 Drug: E2022
E2022 Type D patch
Experimental: 5 Drug: E2022
E2022 Type E patch

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253434

Locations
Japan
Kagoshima, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Tomoo Ogawa Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01253434     History of Changes
Other Study ID Numbers: E2022-J081-001
Study First Received: November 30, 2010
Last Updated: May 13, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Transdermal Administration

ClinicalTrials.gov processed this record on October 23, 2014