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E2022 Patch Formulation Single Dose Phase I Study

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ClinicalTrials.gov Identifier: NCT01253434
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : May 14, 2013
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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

Condition or disease Intervention/treatment Phase
Japanese Healthy Male Adult Volunteers Drug: E2022 Phase 1

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  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: E2022 Patch Formulation Single Dose Phase I Study
Study Start Date : November 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets. [ Time Frame: 15 days ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01253434     History of Changes
Other Study ID Numbers: E2022-J081-001
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: August 2011

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Transdermal Administration