A Phase 1 Comparative Study of E2022 Current and New Patch Formulations

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: E2022- New Formula Tape; Drug: E2022- Current Formula Tape; Drug: E2022 Matching Placebo- New Formula Tape; Drug: E2022 Matching Placebo- Current Formula Tape

Study type: Interventional

Funder types: Industry

Identifiers

NCT02042729

E2022-J081-006

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: Male

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 4 patient groups, including a placebo group

E2022- Tape Formulation

Experimental group

Treatment:

Drug: E2022- Current Formula Tape

Matching Placebo E2022

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: E2022 Matching Placebo- Current Formula Tape

E2022- New Formulation

Active Comparator group

Treatment:

Drug: E2022- New Formula Tape

Placebo E2022- New Formulation

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: E2022 Matching Placebo- New Formula Tape