A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501 - Full Text View

Purpose

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	Intervention	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 Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: immune thrombocytopenia thrombotic thrombocytopenic purpura

Genetic and Rare Diseases Information Center resources: Idiopathic Thrombocytopenic Purpura Immune Thrombocytopenia

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax [ Time Frame: 133 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]


Enrollment:	28
Study Start Date:	January 2012
Study Completion Date:	August 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 55 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549054

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 History of Changes
Other Study ID Numbers:	E5501-G000-012
Study First Received:	January 31, 2012
Last Updated:	October 31, 2013
Health Authority:	European Union: European Medicines Agency

Additional relevant MeSH terms:


Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations	Signs and Symptoms Thrombotic Microangiopathies Thrombocytopenia Blood Platelet Disorders Immune System Diseases Hemorrhagic Disorders Autoimmune Diseases Pharmaceutical Solutions

ClinicalTrials.gov processed this record on September 30, 2016