Healthy Subjects
Conditions
Keywords
Healthy Subjects, Japanese, Males
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).
Interventions
DRUGE2022
transdermal E2022 tape formulation (8.1 cm x 8.1 cm)
Sponsors
Eisai Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and frequency of adverse events | 168 hours after the end of application |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of E2022: Cmax | 216 hours after the end of application | Maximal Drug Concentration (Cmax) |
| Pharmacokinetics of E2022: AUC | 216 hours after the end of application | Area Under the Plasma Concentration-Time Curve (AUC) |
| Pharmacokinetics of E2022: Tmax | 216 hours after the end of application | Time to Reach Maximum Observed Plasma Concentration (Tmax) |
| Pharmacokinetics of E2022: t1/2 | 216 hours after the end of application | Plasma Decay Half-Life (t1/2) |
Countries
Japan
Outcome results
None listed