NCT01253434

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

May 14, 2013

Status Verified

August 1, 2011

Enrollment Period

4 months

First QC Date

November 30, 2010

Last Update Submit

May 13, 2013

Conditions

Japanese Healthy Male Adult Volunteers

Keywords

Transdermal Administration

Outcome Measures

Primary Outcomes (1)

  • Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets.

    15 days

Study Arms (5)

1

EXPERIMENTAL
Drug: E2022

2

EXPERIMENTAL
Drug: E2022

3

EXPERIMENTAL
Drug: E2022

4

EXPERIMENTAL
Drug: E2022

5

EXPERIMENTAL
Drug: E2022

Interventions

E2022DRUG

E2022 Type A patch

1

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)}
  • Subjects who are between 20 and 55 years of age at the time of obtaining written consent.
  • Subjects who are willing to and can comply with the conditions described in the study protocol.

You may not qualify if:

  • Subjects who consumed caffeine-containing food or beverages within 72 hours before study drug administration.
  • 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.
  • Subjects with history of cutaneous hypersensitivity to external preparation, or those who are on another transdermal formulation.
  • Subjects who have excessive skin hair around the region to put the patch on.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kagoshima, Kagoshima-ken, Japan

Location

Study Officials

  • Tomoo Ogawa

    Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2010

First Posted

December 3, 2010

Study Start

November 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

May 14, 2013

Record last verified: 2011-08

Locations

JP(1)