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

Eisai Inc.1 site in 1 country28 target enrollmentJanuary 2012

ConditionsIdiopathic Thrombocytopenic Purpura

Interventions10-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

Drugs10-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

Overview

Phase: Phase 1
Intervention: 10-mg dose of E5501 2G tablet
Conditions: Idiopathic Thrombocytopenic Purpura
Sponsor: Eisai Inc.
Enrollment: 28
Locations: 1
Primary Endpoint: Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

August 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eisai Inc.

Responsible Party

Sponsor

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.