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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01549054
Other study ID # E5501-G000-012
Secondary ID
Status Completed
Phase Phase 1
First received January 31, 2012
Last updated October 31, 2013
Start date January 2012
Est. completion date August 2012

Study information

Verified date October 2013
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date August 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
10-mg dose of E5501 2G tablet
Treatment A: Single 10-mg dose of E5501 2G tablet
10-mg dose of E5501 cyclodextrin oral solution
Treatment B: Single 10-mg dose of E5501 cyclodextrin oral solution
10-mg dose of E5501-P21% powder
Treatment C: Single 10-mg dose of E5501-P21% powder oral suspension
10-mg dose of E5501 lipid-based oral
Treatment D: Single 10-mg dose of E5501 lipid-based oral suspension

Locations

Country Name City State
United Kingdom Quotient Nottingham

Sponsors (1)

Lead Sponsor Collaborator
Eisai Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax 133 days No
Secondary Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax with and without food 133 days No
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