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

Phase 1

Completed

• Conditions: Idiopathic Thrombocytopenic Purpura
• Interventions: Drug: 10-mg dose of E5501 cyclodextrin oral solution; Drug: 10-mg dose of E5501 lipid-based oral; Drug: 10-mg dose of E5501 2G tablet; Drug: 10-mg dose of E5501-P21% powder

• Registration Number: NCT01549054
• Lead Sponsor: Eisai Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-08
• Primary Completion: 2012-06
• Study Completion: 2012-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
10-mg dose of E5501 cyclodextrin oral solution	10-mg dose of E5501 cyclodextrin oral solution	-
10-mg dose of E5501 lipid-based oral	10-mg dose of E5501 lipid-based oral	-
10-mg dose of E5501 2G tablet	10-mg dose of E5501 2G tablet	-
10-mg dose of E5501-P21% powder	10-mg dose of E5501-P21% powder	-

Primary Outcome Measures

Name	Time	Method
Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax	133 days

Secondary Outcome Measures

Name	Time	Method
Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax with and without food	133 days

Trial Locations

Locations (1)

Quotient; 🇬🇧 Nottingham, United Kingdom