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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: E2022- Current Formula Tape; Drug: E2022 Matching Placebo- Current Formula Tape; Drug: E2022- New Formula Tape; Drug: E2022 Matching Placebo- New Formula Tape

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: E2022- Tape Formulation	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.
PLACEBO_COMPARATOR: Matching Placebo E2022; Matching Placebo	Drug: E2022 Matching Placebo- Current Formula Tape; Other Names: Cohort I: E2022 Matching Placebo current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.
ACTIVE_COMPARATOR: E2022- New Formulation	Drug: 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_COMPARATOR: Placebo E2022- New Formulation; Matching Placebo	Drug: E2022 Matching Placebo- New Formula Tape; Other Names: Cohort I: E2022 Matching Placebo new formula tape administered on a skin application site and evaluated for

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Adverse Events	10 days (Cohort I) and 40 days (Cohort II)
Frequency of Adverse Events	10 days (Cohort I) and 40 days (Cohort II)

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic Parameter: Cmax	40 days (Cohort II)
Pharmacokinetic Parameter: Tmax	40 days (Cohort II)
Pharmacokinetic Parameter: AUC	40 days (Cohort II)

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.
• Investigators: Study Director: Hidetaka Hiramatsu, Eisai Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (ESTIMATE): January 23, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 21, 2014
• Last Update Submitted That Met QC Criteria: February 20, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: volunteer
• Other Study ID Numbers: E2022-J081-006