A Phase 1 Comparative Study of E2022 Current and New Patch Formulations

February 20, 2014 updated by: Eisai Co., Ltd.
The purpose of this study is to investigate the safety and pharmacokinetics of new patch formulation (tape) of E2022 by conducting patch test.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 39 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion criteria

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

Exclusion criteria

(Cohort 1 and 2):

  1. 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
  2. Have a clinically significant abnormality or organ dysfunction
  3. Have a history of allergy to drug or food requiring medical treatment or seasonal allergy at screening
  4. Have a history or complication of contact dermatitis or atopic dermatitis
  5. Have hairy back or have shaved within 4 weeks before study treatment
  6. Have a skin disease (e.g., eczema, dermatitis, dyschromatosis), or skin damage (e.g., injury, scar, or sun burn) which may affect skin assessment
  7. Have a history or suspected to have drug or alcohol dependence, or positive for urine drug screen at baseline or a day before screening
  8. Have had caffeine-containing drink or food, or alcohol within 72 hours before study treatment
  9. Have used liquid product (including cosmetics), or applied patch, tape, or bandage on the back within 4 weeks before study treatment
  10. 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):

  1. Meet QTc of greater than 450 milliseconds at screening or immediately before study treatment
  2. 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
  3. Had St. John's Wort-containing preparation within 4 weeks before Period 1 application

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: E2022- Tape Formulation
Drug: E2022- Current Formula Tape

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.
PLACEBO_COMPARATOR: Matching Placebo E2022
Matching Placebo
Drug: E2022 Matching Placebo- Current Formula Tape
Other Names:
  • 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.
ACTIVE_COMPARATOR: E2022- New Formulation
Drug: E2022- New Formula Tape

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.
PLACEBO_COMPARATOR: Placebo E2022- New Formulation
Matching Placebo
Drug: E2022 Matching Placebo- New Formula Tape
Other Names:
  • Cohort I: E2022 Matching Placebo new formula tape administered on a skin application site and evaluated for

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Adverse Events
Time Frame: 10 days (Cohort I) and 40 days (Cohort II)
10 days (Cohort I) and 40 days (Cohort II)
Frequency of Adverse Events
Time Frame: 10 days (Cohort I) and 40 days (Cohort II)
10 days (Cohort I) and 40 days (Cohort II)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pharmacokinetic Parameter: Cmax
Time Frame: 40 days (Cohort II)
40 days (Cohort II)
Pharmacokinetic Parameter: Tmax
Time Frame: 40 days (Cohort II)
40 days (Cohort II)
Pharmacokinetic Parameter: AUC
Time Frame: 40 days (Cohort II)
40 days (Cohort II)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hidetaka Hiramatsu, Eisai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E2022-J081-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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