E2022 Patch Formulation Single Dose Phase I Study

Eisai

Status and phase: Completed; Phase 1

Conditions: Japanese Healthy Male Adult Volunteers

Treatments: Drug: E2022

Study type: Interventional

Funder types: Industry

Identifiers

NCT01253434

E2022-J081-001

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in healthy Japanese male volunteers.

Full description

This study is an open-label single site, randomized single dose study in 80 healthy Japanese male volunteers. The study consists of Period I to Period III, a total of 3 periods. In Period I, E2022 patches will be secured with seal. In Period II, single dose of E2022 5 mg tablet will be administered. In Period III, E2022 patches will be applied without seal. The features of the 5 patches will be evaluated in this study.

Enrollment: 80 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Body Mass Index (BMI) at Screening is 18.5 kg/m2 or above and less than 25.0 kg/m2: BMI (kg/m2)= weight(kg) ÷ {height(m)× height(m)}
2. Subjects who are between 20 and 55 years of age at the time of obtaining written consent.
3. Subjects who are willing to and can comply with the conditions described in the study protocol.

Exclusion Criteria

1. Subjects who consumed caffeine-containing food or beverages within 72 hours before study drug administration.
2. Exposure to any supplements or herbs (including Chinese medicine), or beverages (e.g. alcohol or grapefruit-containing beverages) known to modulate CYP3A4, CYP2C9, CYP2C19, CYP2D6, within 2 weeks before study drug administration.
3. Subjects with history of cutaneous hypersensitivity to external preparation, or those who are on another transdermal formulation.
4. Subjects who have excessive skin hair around the region to put the patch on.
5. Subjects with skin disorder, such as eczema, skin irritation, pigment disorder, injury or scar in the region of patch application, which may have an impact on skin findings.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 5 patient groups

1

Experimental group

Treatment:

Drug: E2022

Drug: E2022

Drug: E2022

Drug: E2022

Drug: E2022

2

Experimental group

Treatment:

Drug: E2022

Drug: E2022

Drug: E2022

Drug: E2022

Drug: E2022

3

Experimental group

Treatment:

Drug: E2022

Drug: E2022

Drug: E2022

Drug: E2022

Drug: E2022

4

Experimental group

Treatment:

Drug: E2022

Drug: E2022

Drug: E2022

Drug: E2022

Drug: E2022

5

Experimental group

Treatment:

Drug: E2022

Drug: E2022

Drug: E2022

Drug: E2022

Drug: E2022