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

• ClinicalTrials.gov Identifier: NCT01549054
• Recruitment Status: Completed
• First Posted: March 8, 2012
• Last Update Posted: November 1, 2013
• Sponsor: Eisai Inc.
• Information provided by (Responsible Party): Eisai Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Idiopathic Thrombocytopenic Purpura	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	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: January 2012
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: August 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax [ Time Frame: 133 days ]

Secondary Outcome Measures :

1. Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax with and without food [ Time Frame: 133 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United Kingdom

Quotient

Nottingham, United Kingdom

Sponsors and Collaborators

Eisai Inc.

Investigators

• Study Director: Bhaskar Rege; Eisai Inc.

More Information

• Responsible Party: Eisai Inc.
• ClinicalTrials.gov Identifier: NCT01549054
• Other Study ID Numbers: E5501-G000-012
• First Posted: March 8, 2012
• Last Update Posted: November 1, 2013
• Last Verified: October 2013

Additional relevant MeSH terms:

Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic; Blood Coagulation Disorders; Hematologic Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Immune System Diseases; Hemorrhagic Disorders; Autoimmune Diseases