E2022 Patch Formulation Single Dose Phase I Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Participants

NCT03922633

Healthy Male Participants

COMPLETED PHASE1

A Study of E2022 Tape Formulation (Overlay-integrated E2022 18 mg Tape Formulation) for Different Application Sites and Intervals in Japanese Healthy Elderly Males

NCT02225288

Healthy Subjects

COMPLETED PHASE1

A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects (Study E6011-J081-001)

NCT01731275

Healthy Male Volunteers

COMPLETED PHASE1

Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2082 in Healthy Male Subjects

NCT03402178

Healthy Participants

TERMINATED PHASE1

A Single Intravenous Dose Study of E3112 in Japanese Healthy Adult Male Subjects

NCT03014895

Healthy Male Volunteers

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Japanese Healthy Male Adult Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

E2022

Intervention Type DRUG

E2022 Type A patch

2

Group Type EXPERIMENTAL

E2022

Intervention Type DRUG

E2022 Type B patch

3

Group Type EXPERIMENTAL

E2022

Intervention Type DRUG

E2022 Type C patch

4

Group Type EXPERIMENTAL

E2022

Intervention Type DRUG

E2022 Type D patch

5

Group Type EXPERIMENTAL

E2022

Intervention Type DRUG

E2022 Type E patch

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

E2022

E2022 Type A patch

Intervention Type DRUG

E2022

E2022 Type B patch

Intervention Type DRUG

E2022

E2022 Type C patch

Intervention Type DRUG

E2022

E2022 Type D patch

Intervention Type DRUG

E2022

E2022 Type E patch

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes