Healthy Subjects Clinical Trial
Verified date | March 2015 |
Source | Eisai Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | February 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 65 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Eisai Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number and frequency of adverse events | 168 hours after the end of application | Yes | |
Secondary | Pharmacokinetics of E2022: Cmax | Maximal Drug Concentration (Cmax) | 216 hours after the end of application | No |
Secondary | Pharmacokinetics of E2022: AUC | Area Under the Plasma Concentration-Time Curve (AUC) | 216 hours after the end of application | No |
Secondary | Pharmacokinetics of E2022: Tmax | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 216 hours after the end of application | No |
Secondary | Pharmacokinetics of E2022: t1/2 | Plasma Decay Half-Life (t1/2) | 216 hours after the end of application | No |
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