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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042729
• Other study ID #: E2022-J081-006
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2014
• Last updated: February 20, 2014
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		10 days (Cohort I) and 40 days (Cohort II)	Yes
Primary	Frequency of Adverse Events		10 days (Cohort I) and 40 days (Cohort II)	Yes
Secondary	Pharmacokinetic Parameter: Cmax		40 days (Cohort II)	No
Secondary	Pharmacokinetic Parameter: Tmax		40 days (Cohort II)	No
Secondary	Pharmacokinetic Parameter: AUC		40 days (Cohort II)	No