NCT02042729

Brief Summary

The purpose of this study is to investigate the safety and pharmacokinetics of new patch formulation (tape) of E2022 by conducting patch test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 2012

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

August 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
Last Updated

February 21, 2014

Status Verified

February 1, 2014

Enrollment Period

2 months

First QC Date

January 21, 2014

Last Update Submit

February 20, 2014

Conditions

Healthy

Keywords

volunteer

Outcome Measures

Primary Outcomes (2)

  • Number of Adverse Events

    10 days (Cohort I) and 40 days (Cohort II)

  • Frequency of Adverse Events

    10 days (Cohort I) and 40 days (Cohort II)

Secondary Outcomes (3)

  • Pharmacokinetic Parameter: Cmax

    40 days (Cohort II)

  • Pharmacokinetic Parameter: Tmax

    40 days (Cohort II)

  • Pharmacokinetic Parameter: AUC

    40 days (Cohort II)

Study Arms (4)

E2022- Tape Formulation

EXPERIMENTAL
Drug: E2022- Current Formula Tape

Matching Placebo E2022

PLACEBO COMPARATOR

Matching Placebo

Drug: E2022 Matching Placebo- Current Formula Tape

E2022- New Formulation

ACTIVE COMPARATOR
Drug: E2022- New Formula Tape

Placebo E2022- New Formulation

PLACEBO COMPARATOR

Matching Placebo

Drug: E2022 Matching Placebo- New Formula Tape

Interventions

E2022- Current Formula TapeDRUG

Cohort I: E2022 current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test. Cohort II: E2022 current formula tape administered to skin application site and evaluated for 20 days.

E2022- Tape Formulation
E2022- New Formula TapeDRUG

Cohort I: E2022 new formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test. Cohort II: E2022 new formula tape administered to skin application site and evaluated for 20 days.

E2022- New Formulation
E2022 Matching Placebo- Current Formula TapeDRUG
Also known as: Cohort I: E2022 Matching Placebo current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.
Matching Placebo E2022
E2022 Matching Placebo- New Formula TapeDRUG
Also known as: Cohort I: E2022 Matching Placebo new formula tape administered on a skin application site and evaluated for
Placebo E2022- New Formulation

Eligibility Criteria

Age20 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smoker or not smoking for 4 weeks or longer before study treatment
  • BMI at screening is greater than or equal to 18.5 kg/m2 or less than 25.0 kg/m2
  • With written informed consent
  • Given full explanation of this study and is willing to and able to comply with study requirements.

You may not qualify if:

  • (Cohort 1 and 2):
  • Have a disorder which affects the evaluation of study drug such as psychiatric, gastrointestinal, hepatic, renal, respiratory, endocrinological, hematological, neurological, or cardiovascular system, or congenital metabolic abnormality
  • Have a clinically significant abnormality or organ dysfunction
  • Have a history of allergy to drug or food requiring medical treatment or seasonal allergy at screening
  • Have a history or complication of contact dermatitis or atopic dermatitis
  • Have hairy back or have shaved within 4 weeks before study treatment
  • Have a skin disease (e.g., eczema, dermatitis, dyschromatosis), or skin damage (e.g., injury, scar, or sun burn) which may affect skin assessment
  • Have a history or suspected to have drug or alcohol dependence, or positive for urine drug screen at baseline or a day before screening
  • Have had caffeine-containing drink or food, or alcohol within 72 hours before study treatment
  • Have used liquid product (including cosmetics), or applied patch, tape, or bandage on the back within 4 weeks before study treatment
  • Had hard exercise at least 5 days a week or a 1-hour or longer hard exercise within 2 weeks before study treatment
  • (Only Cohort 2):
  • Meet QTc of greater than 450 milliseconds at screening or immediately before study treatment
  • Had nutrients, herb preparations (e.g. oriental medicine), other food or drink (e.g., grapefruit-containing juice) which may affect the activity of drug-metabolizing enzyme or transporter within 2 weeks before study treatment
  • Had St. John's Wort-containing preparation within 4 weeks before Period 1 application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Study Officials

  • Hidetaka Hiramatsu

    Eisai Co., Ltd.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 23, 2014

Study Start

August 1, 2012

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

February 21, 2014

Record last verified: 2014-02

Locations

JP(1)