A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501
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| ClinicalTrials.gov Identifier: NCT01549054 |
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Recruitment Status :
Completed
First Posted : March 8, 2012
Last Update Posted : November 1, 2013
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Sponsor:
Eisai Inc.
Information provided by (Responsible Party):
Eisai Inc.
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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 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 |
Resource links provided by the National Library of Medicine
| 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 |
Primary Outcome Measures :
- Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax [ Time Frame: 133 days ]
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 ]
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| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549054
Locations
| United Kingdom | |
| Quotient | |
| Nottingham, United Kingdom | |
Sponsors and Collaborators
Eisai Inc.
Investigators
| Study Director: | Bhaskar Rege | Eisai Inc. |
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01549054 History of Changes |
| Other Study ID Numbers: |
E5501-G000-012 |
| First Posted: | March 8, 2012 Key Record Dates |
| Last Update Posted: | November 1, 2013 |
| Last Verified: | October 2013 |
Additional relevant MeSH terms:
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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 |