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

Eisai

Status and phase: Completed; Phase 1

Conditions: Idiopathic Thrombocytopenic Purpura

Treatments: Drug: 10-mg dose of E5501 lipid-based oral; 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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01549054

E5501-G000-012

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

10-mg dose of E5501 2G tablet

Experimental group

Treatment:

Drug: 10-mg dose of E5501 2G tablet

10-mg dose of E5501 cyclodextrin oral solution

Experimental group

Treatment:

Drug: 10-mg dose of E5501 cyclodextrin oral solution

10-mg dose of E5501-P21% powder

Experimental group

Treatment:

Drug: 10-mg dose of E5501-P21% powder

10-mg dose of E5501 lipid-based oral

Experimental group

Treatment:

Drug: 10-mg dose of E5501 lipid-based oral