A Phase 1 Comparative Study of E2022 Current and New Patch Formulations
NCT ID: NCT02042729
Last Updated: 2014-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2012-08-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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E2022- Tape Formulation
E2022- Current Formula Tape
Cohort I: E2022 current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.
Cohort II: E2022 current formula tape administered to skin application site and evaluated for 20 days.
Matching Placebo E2022
Matching Placebo
E2022 Matching Placebo- Current Formula Tape
E2022- New Formulation
E2022- New Formula Tape
Cohort I: E2022 new formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.
Cohort II: E2022 new formula tape administered to skin application site and evaluated for 20 days.
Placebo E2022- New Formulation
Matching Placebo
E2022 Matching Placebo- New Formula Tape
Interventions
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E2022- Current Formula Tape
Cohort I: E2022 current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.
Cohort II: E2022 current formula tape administered to skin application site and evaluated for 20 days.
E2022- New Formula Tape
Cohort I: E2022 new formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.
Cohort II: E2022 new formula tape administered to skin application site and evaluated for 20 days.
E2022 Matching Placebo- Current Formula Tape
E2022 Matching Placebo- New Formula Tape
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
39 Years
MALE
Yes
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hidetaka Hiramatsu
Role: STUDY_DIRECTOR
Eisai Co., Ltd.
Locations
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Fukuoka, Fukuoka, Japan
Countries
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Other Identifiers
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E2022-J081-006
Identifier Type: -
Identifier Source: org_study_id
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