Clinical trial NCT01843556: A Phase 1 Study of E2022 Tape Formulation for Different Application Sites and Intervals in Japanese Healthy Elderly Males
Official title: A Phase 1 Study of E2022 Tape Formulation for Different Application Sites and Intervals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Elderly Male
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-30
Enrollment: 48
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase 1 study of E2022 tape formulation in healthy elderly males to evaluate the safety and pharmacokinetics.


Eligibility 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 I
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 weeks before Period I
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

Primary outcomes:
measure: Number and frequency of adverse events
timeFrame: 168 hours after the end of application
Secondary outcomes:
measure: Maximal Drug Concentration (CMax)
timeFrame: 216 hours after the end of application
measure: Area Under the Plasma Concentration-Time Curve (AUC)
timeFrame: 216 hours after the end of application
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 216 hours after the end of application
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 216 hours after the end of application
Other outcomes:
Locations:
city: Kagoshima
country: Japan
Study officials:
affiliation: Eisai Co., Ltd.
name: Hidetaka Hiramatsu
role: STUDY_DIRECTOR
References: