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CompletedNCT01253434Updated May 14, 2013

E2022 Patch Formulation Single Dose Phase I Study

A Phase 1 interventional study of E2022 and E2022 in Japanese Healthy Male Adult Volunteers, sponsored by Eisai Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-14.

Sponsored by Eisai Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Japanese Healthy Male Adult Volunteers

Keywords

  • Transdermal Administration
03

In context

Lead sponsor

Eisai Co., Ltd. is the lead sponsor of 149 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    1

    Drug: E2022

  • Experimental
    2

    Drug: E2022

  • Experimental
    3

    Drug: E2022

  • Experimental
    4

    Drug: E2022

  • Experimental
    5

    Drug: E2022

Interventions

  • DrugE2022

    E2022 Type A patch

  • DrugE2022

    E2022 Type B patch

  • DrugE2022

    E2022 Type C patch

  • DrugE2022

    E2022 Type D patch

  • DrugE2022

    E2022 Type E patch

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 site
  • Kagoshima, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01253434
Lead sponsor
Eisai Co., Ltd.
Responsible party
Sponsor
First posted
Dec 3, 2010
Start date
Nov 2010
Primary completion
Mar 2011
Completion
Mar 2011
Last update
May 14, 2013

Study contacts

Tomoo Ogawa
study director · Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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