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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

December 13, 2010
October 31, 2013
January 2010
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01260155 on ClinicalTrials.gov Archive Site
  • 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 ]
  • (1)To determine the effect of a high fat meal on the BA of E5501 in one 40 mg new tablet formulation [ Designated as safety issue: No ]
  • (2) To evaluate the safety of E5501 in healthy subjects. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Subjects
  • 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 A Fasted
    Intervention: Drug: E5501
  • Experimental: Treatment B Fasted
    Intervention: Drug: E5501
  • Experimental: Treatment C Food Effect
    Intervention: Drug: E5501
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01260155
E5501-A001-005
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Franklin Johnson Eisai Inc.
Eisai Inc.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP