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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • Quotient

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 10-mg dose of E5501 2G tablet	Drug: 10-mg dose of E5501 2G tablet; Treatment A: Single 10-mg dose of E5501 2G tablet
EXPERIMENTAL: 10-mg dose of E5501 cyclodextrin oral solution	Drug: 10-mg dose of E5501 cyclodextrin oral solution; Treatment B: Single 10-mg dose of E5501 cyclodextrin oral solution
EXPERIMENTAL: 10-mg dose of E5501-P21% powder	Drug: 10-mg dose of E5501-P21% powder; Treatment C: Single 10-mg dose of E5501-P21% powder oral suspension
EXPERIMENTAL: 10-mg dose of E5501 lipid-based oral	Drug: 10-mg dose of E5501 lipid-based oral; Treatment D: Single 10-mg dose of E5501 lipid-based oral suspension

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Investigators: Study Director: Bhaskar Rege, Eisai Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: January 31, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (ESTIMATE): March 8, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 1, 2013
• Last Update Submitted That Met QC Criteria: October 31, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Thrombocytopenia; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
• Other Study ID Numbers: E5501-G000-012