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

NCT ID: NCT02225288

Last Updated: 2015-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-02-28

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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 \[applying in the morning and removing next morning\])

Group Type: EXPERIMENTAL

E2022

Intervention Type: DRUG

transdermal E2022 tape formulation (8.1 cm x 8.1 cm)

Group B

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 \[applying in the morning and removing next morning\])

Group Type: EXPERIMENTAL

E2022

Intervention Type: DRUG

transdermal E2022 tape formulation (8.1 cm x 8.1 cm)

Group C

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 \[applying in the morning and removing next morning\])

Group Type: EXPERIMENTAL

E2022

Intervention Type: DRUG

transdermal E2022 tape formulation (8.1 cm x 8.1 cm)

Group D

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 \[applying in the morning and removing next morning\])

Group Type: EXPERIMENTAL

E2022

Intervention Type: DRUG

transdermal E2022 tape formulation (8.1 cm x 8.1 cm)

Interventions

E2022

transdermal E2022 tape formulation (8.1 cm x 8.1 cm)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male non-smokers (not smoking at least 4 weeks before Period 1) aged 65 years or older at informed consent

2. BMI at screening is 18.5 kg/m2 or above - below 28.0 kg/m2

3. Written informed consent

4. Given full explanation of this study and is willing to and able to comply with the protocol requirements

Exclusion Criteria

1. 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

2. 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

3. Have a history of gastrointestinal surgery (e.g., liver, kidney, digestive tract) which affects the pharmacokinetics of study drug

4. Have a history of treatment-requiring drug or food allergy or seasonal allergy at screening

5. Had caffeine-containing food or drink or alcohol within 72 hours before study drug application in Period 1

6. 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

7. Have used liquid products (including cosmetics) on study application sites (back, upper limb, chest), patch, tape or bandage, within 4 weeks before Period 1

8. Present or past clinical signs of skin hypersensitivity to topical product or atopic dermatitis

9. Excessively hairy or have shaved at application sites (back, upper limb, chest) within 4 weeks before Period 1

10. Eczema, dermatitis, abnormal pigmentation, injury, or scar at application sites which may affect the evaluation of skin symptoms

• Minimum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kagoshima, Kagoshima-ken, Japan

Countries

Japan

Other Identifiers

E2022-J081-007

Identifier Type: -

Identifier Source: org_study_id