MedDataX Logo

A Single-Center, Open-Label, Randomized, 3-Treatment Crossover Bioavailability Study of Single Oral Doses of E5501 Old Tablet Formulation Under Fasted Conditions and a New Tablet Formulation Under Fed and Fasted Conditions in Healthy Subjects

NCT ID: NCT01260155

Last Updated: 2013-11-01

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-06-30

Brief Summary

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

This study will be a single-center, open-label, randomized, 3-treatment crossover bioavailability study of single oral doses of E5501 old tablet formulation under fasted conditions and a new tablet formulation administered under fed and fasted conditions in healthy subjects.

Detailed Description

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

Conditions

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

Healthy Subjects

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Treatment A Fasted

Group Type EXPERIMENTAL

E5501

Intervention Type DRUG

Treatment A: 40 mg new tablet formulation (1 tablet) under fasted conditions

Treatment B Fasted

Group Type EXPERIMENTAL

E5501

Intervention Type DRUG

Treatment B: 20 mg old tablet formulation (2 tablets) under fasted conditions

Treatment C Food Effect

Group Type EXPERIMENTAL

E5501

Intervention Type DRUG

Treatment C: 40 mg new tablet formulation administered with food

Interventions

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

E5501

Treatment A: 40 mg new tablet formulation (1 tablet) under fasted conditions

Intervention Type DRUG

E5501

Treatment B: 20 mg old tablet formulation (2 tablets) under fasted conditions

Intervention Type DRUG

E5501

Treatment C: 40 mg new tablet formulation administered with food

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Normal healthy adult males and females (age 18-45 years)
* Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 32 at the time of Screening
* All females must have a negative serum human beta-chorionic gonadotropin test result or negative urine pregnancy test result at Screening and Baseline. Females of child-bearing potential must use a medically acceptable method of contraception throughout the entire study period and for 30 days after study drug discontinuation. Postmenopausal women and women who have been surgically sterilized or are proven sterile are exempt from this requirement. All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.
* Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of child-bearing potential must use, or their partners must use, a highly effective,method of contraception starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days after the last dose of study drug.
* Willing and able to comply with all aspects of the protocol
* Provide written informed consent

Exclusion Criteria

* Standard selection criteria typically used in all protocols
* Clinically significant abnormal laboratory test results, including platelet count and electrolyte abnormalities at Screening and at each Baseline
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Franklin Johnson

Role: STUDY_DIRECTOR

Eisai Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Celerion

Phoenix, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E5501-A001-005

Identifier Type: -

Identifier Source: org_study_id