Status:
COMPLETED
A Study of E2022 Tape Formulation (Overlay-integrated E2022 18 mg Tape Formulation) for Different Application Sites and Intervals in Japanese Healthy Elderly Males
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Healthy Subjects
Eligibility:
MALE
65+ years
Phase:
PHASE1
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 E202...
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02225288
Start Date
September 1 2014
End Date
February 1 2015
Last Update
April 2 2015
Active Locations (1)
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1
Kagoshima, Kagoshima-ken, Japan