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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: E2022

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).

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kagoshima, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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])	Drug: E2022; transdermal E2022 tape formulation (8.1 cm x 8.1 cm)
EXPERIMENTAL: 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])	Drug: E2022; transdermal E2022 tape formulation (8.1 cm x 8.1 cm)
EXPERIMENTAL: 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])	Drug: E2022; transdermal E2022 tape formulation (8.1 cm x 8.1 cm)
EXPERIMENTAL: 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])	Drug: E2022; transdermal E2022 tape formulation (8.1 cm x 8.1 cm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number and frequency of adverse events	168 hours after the end of application

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: August 22, 2014
• First Submitted That Met QC Criteria: August 22, 2014
• First Posted (ESTIMATE): August 26, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 2, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Japanese; Healthy Subjects; Males
• Other Study ID Numbers: E2022-J081-007