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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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01289509
First received: January 27, 2011
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Idiopathic Thrombocytopenia Purpura
 Drug: E5501
Drug: 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 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

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). [ 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 ]

Secondary Outcome Measures:
  • • 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 ]

Estimated Enrollment: 42
Study Start Date: December 2010
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental 1
Drug: E5501
 Drug: E5501
Lot P01010ZZA (test) single oral doses of 40 mg tablets.
Experimental: Experimental 2
Drug: E5501
 Drug: Drug: E5501
Lot P97001ZZB (reference) single oral doses of 40 mg tablets.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289509

Locations
United States, Kansas
PRA
Lenexa, Kansas, United States
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Franklin Johnson Eisai Inc.
  More Information

No publications provided

Responsible Party: Franklin Johnson/Study Director, Eisai, Inc.
ClinicalTrials.gov Identifier: NCT01289509     History of Changes
Other Study ID Numbers: E5501-A001-007
Study First Received: January 27, 2011
Last Updated: June 15, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Purpura
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
 Skin Manifestations
Signs and Symptoms
Blood Platelet Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 13, 2013