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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: E5501; Drug: E5501; Drug: E5501

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A Fasted	Drug: E5501; Treatment A: 40 mg new tablet formulation (1 tablet) under fasted conditions; Drug: E5501; Treatment B: 20 mg old tablet formulation (2 tablets) under fasted conditions; Drug: E5501; Treatment C: 40 mg new tablet formulation administered with food
Experimental: Treatment B Fasted	Drug: E5501; Treatment A: 40 mg new tablet formulation (1 tablet) under fasted conditions; Drug: E5501; Treatment B: 20 mg old tablet formulation (2 tablets) under fasted conditions; Drug: E5501; Treatment C: 40 mg new tablet formulation administered with food
Experimental: Treatment C Food Effect	Drug: E5501; Treatment A: 40 mg new tablet formulation (1 tablet) under fasted conditions; Drug: E5501; Treatment B: 20 mg old tablet formulation (2 tablets) under fasted conditions; Drug: E5501; Treatment C: 40 mg new tablet formulation administered with food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the bioavailability (BA) of E5501 in one 40 mg new tablet formulation relative to two 20 mg old tablet formulation.	2 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Investigators: Study Director: Franklin Johnson, Eisai Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: December 13, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimate): December 15, 2010

Study Record Updates

• Last Update Posted (Estimate): November 1, 2013
• Last Update Submitted That Met QC Criteria: October 31, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Disease; Malnutrition
• Other Study ID Numbers: E5501-A001-005