A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01549054
First received: January 31, 2012
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

This is a study in healthy subjects. There are two parts to the study. In the first part of the study each subject will receive a single 10mg dose of each of the four formulations of E550. Based on the results from Part 1, an optimal formulation will be selected for further evaluation in Part 2.


Condition Intervention Phase
Idiopathic Thrombocytopenic Purpura
Drug: 10-mg dose of E5501 2G tablet
Drug: 10-mg dose of E5501 cyclodextrin oral solution
Drug: 10-mg dose of E5501-P21% powder
Drug: 10-mg dose of E5501 lipid-based oral
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-center, Randomized, Open-label, Two-part Study to Evaluate Bioavailability of Prototype Third-generation Formulations of E5501 Relative to Second-generation Tablet Formulation in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax [ Time Frame: 133 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax with and without food [ Time Frame: 133 days ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10-mg dose of E5501 2G tablet Drug: 10-mg dose of E5501 2G tablet
Treatment A: Single 10-mg dose of E5501 2G tablet
Experimental: 10-mg dose of E5501 cyclodextrin oral solution Drug: 10-mg dose of E5501 cyclodextrin oral solution
Treatment B: Single 10-mg dose of E5501 cyclodextrin oral solution
Experimental: 10-mg dose of E5501-P21% powder Drug: 10-mg dose of E5501-P21% powder
Treatment C: Single 10-mg dose of E5501-P21% powder oral suspension
Experimental: 10-mg dose of E5501 lipid-based oral Drug: 10-mg dose of E5501 lipid-based oral
Treatment D: Single 10-mg dose of E5501 lipid-based oral suspension

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult men and women (age ≥ 18 to ≤ 55 years)
  • Body mass index ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at the time of screening and baseline of Treatment Period 1
  • Platelet count between 120 x 109/L and 300 x 109/L at baseline of each Treatment Period 1, 3, and 5
  • Women of child bearing potential must agree to use a highly effective method of contraception, other than estrogen-based hormonal contraceptives, during the Treatment Phase of the study.

In addition, other standard criteria for healthy subjects will be used.

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 PK of study drug
  • Agents associated with thrombotic events (including oral contraceptives) must be discontinued within 30 days of first study drug administration
  • Evidence of organ dysfunction or any clinically significant event or illness in the subject's medical history, e.g., history of splenectomy.
  • History of arterial or venous thrombosis, including partial or complete thrombosis (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism). Known family history of hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency, etc.)
  • Hemoglobin less than the lower limit of normal levels.

In addition, other standard criteria for healthy subjects will be used.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549054

Locations
United Kingdom
Quotient
Nottingham, United Kingdom
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Bhaskar Rege Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01549054     History of Changes
Other Study ID Numbers: E5501-G000-012
Study First Received: January 31, 2012
Last Updated: October 31, 2013
Health Authority: European Union: European Medicines Agency

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

ClinicalTrials.gov processed this record on April 17, 2014