Clinical trial NCT02042729: A Phase 1 Comparative Study of E2022 Current and New Patch Formulations
Official title: A Phase 1 Comparative Study of E2022 Current and New Patch Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: volunteer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-23
Enrollment: 34
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and pharmacokinetics of new patch formulation (tape) of E2022 by conducting patch test.


Eligibility criteria: Inclusion criteria

1. Non-smoker or not smoking for 4 weeks or longer before study treatment
2. BMI at screening is greater than or equal to 18.5 kg/m2 or less than 25.0 kg/m2
3. With written informed consent
4. Given full explanation of this study and is willing to and able to comply with study requirements.

Exclusion criteria

(Cohort 1 and 2):

1. Have a disorder which affects the evaluation of study drug such as psychiatric, gastrointestinal, hepatic, renal, respiratory, endocrinological, hematological, neurological, or cardiovascular system, or congenital metabolic abnormality
2. Have a clinically significant abnormality or organ dysfunction
3. Have a history of allergy to drug or food requiring medical treatment or seasonal allergy at screening
4. Have a history or complication of contact dermatitis or atopic dermatitis
5. Have hairy back or have shaved within 4 weeks before study treatment
6. Have a skin disease (e.g., eczema, dermatitis, dyschromatosis), or skin damage (e.g., injury, scar, or sun burn) which may affect skin assessment
7. Have a history or suspected to have drug or alcohol dependence, or positive for urine drug screen at baseline or a day before screening
8. Have had caffeine-containing drink or food, or alcohol within 72 hours before study treatment
9. Have used liquid product (including cosmetics), or applied patch, tape, or bandage on the back within 4 weeks before study treatment
10. Had hard exercise at least 5 days a week or a 1-hour or longer hard exercise within 2 weeks before study treatment

(Only Cohort 2):

1. Meet QTc of greater than 450 milliseconds at screening or immediately before study treatment
2. Had nutrients, herb preparations (e.g. oriental medicine), other food or drink (e.g., grapefruit-containing juice) which may affect the activity of drug-metabolizing enzyme or transporter within 2 weeks before study treatment
3. Had St. John's Wort-containing preparation within 4 weeks before Period 1 application

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 10 days (Cohort I) and 40 days (Cohort II)
measure: Frequency of Adverse Events
timeFrame: 10 days (Cohort I) and 40 days (Cohort II)
Secondary outcomes:
measure: Pharmacokinetic Parameter: Cmax
timeFrame: 40 days (Cohort II)
measure: Pharmacokinetic Parameter: Tmax
timeFrame: 40 days (Cohort II)
measure: Pharmacokinetic Parameter: AUC
timeFrame: 40 days (Cohort II)
Other outcomes:
Locations:
city: Fukuoka
country: Japan
Study officials:
affiliation: Eisai Co., Ltd.
name: Hidetaka Hiramatsu
role: STUDY_DIRECTOR
References: