Healthy SubjectsPhase 1NCT02225288

A Study of E2022 Tape Formulation (Overlay-integrated E2022 18 mg Tape Formulation) for Different Application Sites and Intervals in Japanese Healthy Elderly Males

A Phase 1 study testing E2022 in people with Healthy Subjects, run by Eisai Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a single-center, 4-group, open-label study in Japanese healthy elderly males. A total of 48 subjects will be randomized to one of four groups (A to D, 12 subjects/group) to administer one E2022 tape to designated sites. Read more about this study

Who is it for?: Ages 65 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: E2022
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteJapan
Study dates: Sep 2014to Feb 2015
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
Men only
Healthy volunteers accepted
Older adult

Who may be able to join

Male non-smokers (not smoking at least 4 weeks before Period 1) aged 65 years or older at informed consent
BMI at screening is 18.5 kg/m2 or above - below 28.0 kg/m2
Written informed consent
Given full explanation of this study and is willing to and able to comply with the protocol requirements

Who cannot join

Have a current or past history of disorder requiring medical treatment within 8 weeks before the first application or infection within 4 weeks before the first application
Have a disorder within 4 weeks before the first application 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 history of gastrointestinal surgery (e.g., liver, kidney, digestive tract) which affects the pharmacokinetics of study drug
Have a history of treatment-requiring drug or food allergy or seasonal allergy at screening
Had caffeine-containing food or drink or alcohol within 72 hours before study drug application in Period 1
Had nutritional supplements, herbal preparations (including oriental medicines) or others (e.g., grapefruit-containing food or beverage) which may affect drug metabolizing enzymes and transporters, within 1 week before Period 1

Show all 10Show fewer

Have used liquid products (including cosmetics) on study application sites (back, upper limb, chest), patch, tape or bandage, within 4 weeks before Period 1
Present or past clinical signs of skin hypersensitivity to topical product or atopic dermatitis
Excessively hairy or have shaved at application sites (back, upper limb, chest) within 4 weeks before Period 1
Eczema, dermatitis, abnormal pigmentation, injury, or scar at application sites which may affect the evaluation of skin symptoms

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Kagoshima, Kagoshima-ken

Other trials in Japan

About this study

Read the detailed description

This study consists of Screening, Treatment Period, and Follow-up. The Treatment Period is subdivided into three periods (Periods 1 to 3). Screening will start within 4 weeks before starting Treatment Period 1. In Treatment Periods 1 and 2, one E2022 tape will be applied to the designated site. The Treatment Period 2 application must have at least a 17-day interval from the end of Treatment Period 1 application. In Treatment Period 3, E2022 tape will be applied to back site (contralateral to the first applied site during Treatment Periods 1 and 2) after at least 17 days from the end of Treatment Period 2 (removing). A new E2022 tape will be applied to the same site after the specified intervals from the end of previous application (removing) in each group. Follow-up will start after at least a 17-day interval from the end of re-application in the Treatment Period 3 (removing).

Conditions: Healthy Subjects
Being tested: E2022
Keywords: Healthy Subjects, Japanese, Males

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E2022Drug
transdermal E2022 tape formulation (8.1 cm x 8.1 cm)

Study groups in NCT02225288
Study group	Role	What they receive
Group A	Experimental	Period 1: Apply one E2022 tape to the designated site (back or upper arm) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or upper arm, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group A: 48 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning]) Receives: Drug: E2022
Group B	Experimental	Period 1: Apply one E2022 tape to the designated site (back or upper arm) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or upper arm, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group B: 72 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning]) Receives: Drug: E2022
Group C	Experimental	Period 1: Apply one E2022 tape to the designated site (back or chest) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or chest, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group C: 96 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning]) Receives: Drug: E2022
Group D	Experimental	Period 1: Apply one E2022 tape to the designated site (back or chest) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or chest, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group D: 120 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning]) Receives: Drug: E2022

What is being measured

The primary outcome is the main question the study is designed to answer.

Number and frequency of adverse events
Measured: 168 hours after the end of application

Secondary outcomes (4)

Pharmacokinetics of E2022: Cmax
Maximal Drug Concentration (Cmax)
Measured: 216 hours after the end of application
Pharmacokinetics of E2022: AUC
Area Under the Plasma Concentration-Time Curve (AUC)
Measured: 216 hours after the end of application
Pharmacokinetics of E2022: Tmax
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 216 hours after the end of application
Pharmacokinetics of E2022: t1/2
Plasma Decay Half-Life (t1/2)
Measured: 216 hours after the end of application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Feb 2015

First posted26 Aug 2014 (estimated)
Study startSep 2014
Primary completionDec 2014
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02225288
Sponsor's protocol ID: E2022-J081-007
Status last verified: Mar 2015
First submitted: 22 Aug 2014
Last updated: 2 Apr 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of E2022 Tape Formulation (Overlay-integrated E2022 18 mg Tape Formulation) for Different Application Sites and Intervals in Japanese Healthy Elderly Males
ClinicalTrials.gov ID: NCT02225288
Acronym / sponsor ID: E2022-J081-007
Conditions: Healthy Subjects
Keywords: Healthy Subjects, Japanese, Males
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Eisai Co., Ltd.Industry (pharma, biotech, devices)
Study start: Sep 2014
Primary completion: Dec 2014 (actual)
Study completion: Feb 2015 (actual)
First posted: 26 Aug 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group A	Experimental	Drug: E2022Period 1: Apply one E2022 tape to the designated site (back or upper arm) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or upper arm, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group A: 48 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning])
Group B	Experimental	Drug: E2022Period 1: Apply one E2022 tape to the designated site (back or upper arm) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or upper arm, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group B: 72 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning])
Group C	Experimental	Drug: E2022Period 1: Apply one E2022 tape to the designated site (back or chest) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or chest, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group C: 96 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning])
Group D	Experimental	Drug: E2022Period 1: Apply one E2022 tape to the designated site (back or chest) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or chest, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group D: 120 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning])

Who may qualify

Ages: 65 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

Male non-smokers (not smoking at least 4 weeks before Period 1) aged 65 years or older at informed consent
BMI at screening is 18.5 kg/m2 or above - below 28.0 kg/m2
Written informed consent
Given full explanation of this study and is willing to and able to comply with the protocol requirements

Key exclusion criteria (10 listed)

Have a current or past history of disorder requiring medical treatment within 8 weeks before the first application or infection within 4 weeks before the first application
Have a disorder within 4 weeks before the first application 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 history of gastrointestinal surgery (e.g., liver, kidney, digestive tract) which affects the pharmacokinetics of study drug
Have a history of treatment-requiring drug or food allergy or seasonal allergy at screening
Had caffeine-containing food or drink or alcohol within 72 hours before study drug application in Period 1

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
E2022transdermal E2022 tape formulation (8.1 cm x 8.1 cm)	Drug	Group A, Group B, Group C, Group D

Primary outcome

Number and frequency of adverse events
Time frame: 168 hours after the end of application

4 secondary outcomes

Pharmacokinetics of E2022: Cmax
Time frame: 216 hours after the end of application
Pharmacokinetics of E2022: AUC
Time frame: 216 hours after the end of application
Pharmacokinetics of E2022: Tmax
Time frame: 216 hours after the end of application
Pharmacokinetics of E2022: t1/2
Time frame: 216 hours after the end of application

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E2022 in people with Healthy Subjects, run by Eisai Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and frequency of adverse events (time frame: 168 hours after the end of application). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02225288.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015.