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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01260155
First received: December 13, 2010
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Drug: E5501
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effect of a high fat meal on the BA of E5501 in one 40 mg new tablet formulation [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • To evaluate the safety of E5501 in healthy subjects. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A Fasted Drug: E5501
Treatment A: 40 mg new tablet formulation (1 tablet) under fasted conditions
Experimental: Treatment B Fasted Drug: E5501
Treatment B: 20 mg old tablet formulation (2 tablets) under fasted conditions
Experimental: Treatment C Food Effect Drug: E5501
Treatment C: 40 mg new tablet formulation administered with food

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260155

Locations
United States, Arizona
Celerion
Phoenix, Arizona, United States
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Franklin Johnson Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01260155     History of Changes
Other Study ID Numbers: E5501-A001-005
Study First Received: December 13, 2010
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 21, 2014