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

Primary Purpose

Idiopathic Thrombocytopenic Purpura

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

10-mg dose of E5501 2G tablet

10-mg dose of E5501 cyclodextrin oral solution

10-mg dose of E5501-P21% powder

10-mg dose of E5501 lipid-based oral

About this trial

This is an interventional treatment trial for Idiopathic Thrombocytopenic Purpura

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Quotient

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

10-mg dose of E5501 2G tablet

10-mg dose of E5501 cyclodextrin oral solution

10-mg dose of E5501-P21% powder

10-mg dose of E5501 lipid-based oral

Arm Description

Outcomes

Primary Outcome Measures

Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax

Secondary Outcome Measures

Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax with and without food

Full Information

NCT ID

NCT01549054

First Posted

January 31, 2012

Last Updated

October 31, 2013

Sponsor

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01549054

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eisai Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Thrombocytopenic Purpura

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

10-mg dose of E5501 2G tablet

Arm Type

Experimental

Arm Title

10-mg dose of E5501 cyclodextrin oral solution

Arm Type

Experimental

Arm Title

10-mg dose of E5501-P21% powder

Arm Type

Experimental

Arm Title

10-mg dose of E5501 lipid-based oral

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

10-mg dose of E5501 2G tablet

Intervention Description

Treatment A: Single 10-mg dose of E5501 2G tablet

Intervention Type

Drug

Intervention Name(s)

10-mg dose of E5501 cyclodextrin oral solution

Intervention Description

Treatment B: Single 10-mg dose of E5501 cyclodextrin oral solution

Intervention Type

Drug

Intervention Name(s)

10-mg dose of E5501-P21% powder

Intervention Description

Treatment C: Single 10-mg dose of E5501-P21% powder oral suspension

Intervention Type

Drug

Intervention Name(s)

10-mg dose of E5501 lipid-based oral

Intervention Description

Treatment D: Single 10-mg dose of E5501 lipid-based oral suspension

Primary Outcome Measure Information:

Title

Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax

Time Frame

133 days

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bhaskar Rege

Organizational Affiliation

Eisai Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Quotient

City

Nottingham

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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