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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10-mg dose of E5501 2G tablet | Experimental |
| |
| 10-mg dose of E5501 cyclodextrin oral solution | Experimental |
| |
| 10-mg dose of E5501-P21% powder | Experimental |
| |
| 10-mg dose of E5501 lipid-based oral | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10-mg dose of E5501 2G tablet | Drug | Treatment A: Single 10-mg dose of E5501 2G tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax | 133 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax with and without food | 133 days |
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Inclusion Criteria:
In addition, other standard criteria for healthy subjects will be used.
Exclusion Criteria:
In addition, other standard criteria for healthy subjects will be used.
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| Name | Affiliation | Role |
|---|---|---|
| Bhaskar Rege | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient | Nottingham | United Kingdom |
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| 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 |
|
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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