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OpenTrials
Completed

NCT Number: NCT01549054

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

10-mg dose of E5501 2G tablet

Drug

Treatment A: Single 10-mg dose of E5501 2G tablet

10-mg dose of E5501 cyclodextrin oral solution

Drug

Treatment B: Single 10-mg dose of E5501 cyclodextrin oral solution

10-mg dose of E5501-P21% powder

Drug

Treatment C: Single 10-mg dose of E5501-P21% powder oral suspension

10-mg dose of E5501 lipid-based oral

Drug

Treatment D: Single 10-mg dose of E5501 lipid-based oral suspension

Primary outcomes

  1. Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax

    Time frame: 133 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2012
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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