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

NCT ID: NCT01549054

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Thrombocytopenic Purpura

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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10-mg dose of E5501 2G tablet

Group Type EXPERIMENTAL

10-mg dose of E5501 2G tablet

Intervention Type DRUG

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

10-mg dose of E5501 cyclodextrin oral solution

Group Type EXPERIMENTAL

10-mg dose of E5501 cyclodextrin oral solution

Intervention Type DRUG

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

10-mg dose of E5501-P21% powder

Group Type EXPERIMENTAL

10-mg dose of E5501-P21% powder

Intervention Type DRUG

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

10-mg dose of E5501 lipid-based oral

Group Type EXPERIMENTAL

10-mg dose of E5501 lipid-based oral

Intervention Type DRUG

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

Interventions

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10-mg dose of E5501 2G tablet

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

Intervention Type DRUG

10-mg dose of E5501 cyclodextrin oral solution

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

Intervention Type DRUG

10-mg dose of E5501-P21% powder

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

Intervention Type DRUG

10-mg dose of E5501 lipid-based oral

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bhaskar Rege

Role: STUDY_DIRECTOR

Eisai Inc.

Locations

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Quotient

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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E5501-G000-012

Identifier Type: -

Identifier Source: org_study_id