Back to resultsA 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
Primary Purpose
Idiopathic Thrombocytopenia Purpura
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
E5501
Drug: E5501
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Thrombocytopenia Purpura
Eligibility Criteria
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
Sites / Locations
- PRA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental 1
Experimental 2
Arm Description
Drug: E5501
Drug: E5501
Outcomes
Primary Outcome Measures
• 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).
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).
Secondary Outcome Measures
• To assess the intra-subject and inter-subject variability in Cmax following replicate dosing with E5501 40 mg lots
• To assess the intra-subject and inter-subject variability in AUC(0-inf) following replicate dosing with E5501 40 mg lots.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01289509
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Thrombocytopenia Purpura
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental 1
Arm Type
Experimental
Arm Description
Drug: E5501
Arm Title
Experimental 2
Arm Type
Experimental
Arm Description
Drug: E5501
Intervention Type
Drug
Intervention Name(s)
E5501
Intervention Description
Lot P01010ZZA (test) single oral doses of 40 mg tablets.
Intervention Type
Drug
Intervention Name(s)
Drug: E5501
Intervention Description
Lot P97001ZZB (reference) single oral doses of 40 mg tablets.
Primary Outcome Measure Information:
Title
• 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
Title
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
Secondary Outcome Measure Information:
Title
• To assess the intra-subject and inter-subject variability in Cmax following replicate dosing with E5501 40 mg lots
Time Frame
10 weeks
Title
• 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franklin Johnson
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
Facility Name
PRA
City
Lenexa
State/Province
Kansas
Country
United States
12. IPD Sharing Statement
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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
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