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

Idiopathic Thrombocytopenic Purpura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549054
• Other study ID #: E5501-G000-012
• 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

• Idiopathic Thrombocytopenic Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

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