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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 April 2015
• Main ID: NCT02225288
• Date of registration: 22/08/2014
• Prospective Registration: Yes
• Primary sponsor: Eisai Co., Ltd.
• Public 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
• Date of first enrolment: September 2014
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02225288
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Japan

Key inclusion & exclusion 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



Age minimum: 65 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy Subjects

Intervention(s)

Drug: E2022

Primary Outcome(s)

Number and frequency of adverse events [Time Frame: 168 hours after the end of application]

Secondary Outcome(s)

Pharmacokinetics of E2022: AUC [Time Frame: 216 hours after the end of application]

Pharmacokinetics of E2022: Cmax [Time Frame: 216 hours after the end of application]

Pharmacokinetics of E2022: t1/2 [Time Frame: 216 hours after the end of application]

Pharmacokinetics of E2022: Tmax [Time Frame: 216 hours after the end of application]

Secondary ID(s)

E2022-J081-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors