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

Eisai Inc.1 site in 1 country16 target enrollmentJanuary 2010

ConditionsHealthy Subjects

InterventionsE5501

Overview

Phase: Phase 1
Intervention: E5501
Conditions: Healthy Subjects
Sponsor: Eisai Inc.
Enrollment: 16
Locations: 1
Primary Endpoint: To determine the bioavailability (BA) of E5501 in one 40 mg new tablet formulation relative to two 20 mg old tablet formulation.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

June 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Eisai Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Treatment A Fasted

Intervention: E5501

Treatment B Fasted

Intervention: E5501

Treatment C Food Effect

Intervention: E5501

Outcomes

Primary Outcomes

To determine the bioavailability (BA) of E5501 in one 40 mg new tablet formulation relative to two 20 mg old tablet formulation.

Time Frame: 2 months

Secondary Outcomes

To evaluate the safety of E5501 in healthy subjects.(2 months)
To determine the effect of a high fat meal on the BA of E5501 in one 40 mg new tablet formulation(2 months)