A Study to Evaluate the Relative Bioavailability and Intra-Subject Variability of Two Lots of E5501 40 mg Tablets Administered Twice as Single Oral Doses to Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01289509
First received: January 27, 2011
Last updated: October 31, 2013
Last verified: October 2013

January 27, 2011
October 31, 2013
December 2010
March 2011   (final data collection date for primary outcome measure)
  • • To evaluate the bioavailability (BA) , as measured by AUC point estimates of E5501 40 mg tablet Lot P01010ZZA (test) relative to E5501 40 mg tablet Lot P97001ZZB (reference). [ Time Frame: 96 hours post-dose ] [ Designated as safety issue: No ]
  • To evaluate the bioavailability, as measured by Cmax point estimates of E5501 40 mg tablet Lot P01010ZZA (test) relative to E5501 40 mg tablet Lot P97001ZZB (reference). [ Time Frame: 96 hours post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01289509 on ClinicalTrials.gov Archive Site
  • • To assess the intra-subject and inter-subject variability in Cmax following replicate dosing with E5501 40 mg lots [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • • To assess the intra-subject and inter-subject variability in AUC(0-inf) following replicate dosing with E5501 40 mg lots. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Relative Bioavailability and Intra-Subject Variability of Two Lots of E5501 40 mg Tablets Administered Twice as Single Oral Doses to Healthy Subjects
A Randomized, Open-Label, 4-Way Crossover Replicate Design Study to Evaluate the Relative Bioavailability and Intra-Subject Variability of Two Lots of E5501 40 mg Tablets Administered Twice as Single Oral Doses to Healthy Subjects

The purpose of this study is to evaluate the relative bioavailability (BA) of two lots of E5501 40 mg tablets administered twice as single oral doses to healthy subjects.

This is a randomized, open label, 4- way crossover, replicate design study to evaluate the bioavailability (BA) of E5501 new Phase 3 formulation Lot P97001ZZB 40 mg tablet manufactured July, 2009 (Treatment A ,reference drug) relative to Lot P01010ZZA 40 mg tablet manufactured January, 2010 (Treatment B, test drug) administered to 42 healthy male and female subjects.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Idiopathic Thrombocytopenia Purpura
  • Drug: E5501
    Lot P01010ZZA (test) single oral doses of 40 mg tablets.
  • Drug: Drug: E5501
    Lot P97001ZZB (reference) single oral doses of 40 mg tablets.
  • Experimental: Experimental 1
    Drug: E5501
    Intervention: Drug: E5501
  • Experimental: Experimental 2
    Drug: E5501
    Intervention: Drug: 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
42
May 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Normal healthy adult male or female subjects age greater than or equal to 18 years and less than or equal to 55 years old.
  • Body mass index greater than or equal to 18 kg/m2 and less than or equal to 32 kg/m2 at the time of screening.
  • Platelet count between 120x109/L and 250x109/L.
  • Women of childbearing potential must agree to use a double barrier method of contraception during the Randomization Phase of the study.

Exclusion Criteria:

  • Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the pharmacokinetics (PK)of the study drug.
  • Agents associated with thrombotic events (including oral contraceptives) must be discontinued within 30 days of the first study drug administration.
  • Evidence of organ dysfunction or any clinically significant deviation from normal in their medical history, e.g., history of splenectomy.
  • History of venous or arterial thrombotic disease or other hypercoaguable state.
  • Hemoglobin level less than 11.5 g/dL for females and 13.5g /dL for males
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01289509
E5501-A001-007
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