Doptelet (avatrombopag) / SOBI |
NCT01260155: A Single-Center, Open-Label, Randomized, 3-Treatment Crossover Bioavailability Study of Single Oral Doses of E5501 Old Tablet Formulation Under Fasted Conditions and a New Tablet Formulation Under Fed and Fasted Conditions in Healthy Subjects |
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| Completed | 1 | 16 | US | E5501 | Eisai Inc. | Healthy Subjects | 06/10 | 06/10 | | |
| Completed | 1 | 36 | US | E5501 | Eisai Inc. | Healthy Subjects | 01/11 | | | |
NCT01289509: A Study to Evaluate the Relative Bioavailability and Intra-Subject Variability of Two Lots of E5501 40 mg Tablets Administered Twice as Single Oral Doses to Healthy Subjects |
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| Completed | 1 | 42 | US | E5501, Drug: E5501 | Eisai Inc. | Idiopathic Thrombocytopenia Purpura | 03/11 | 05/11 | | |
NCT01327872: Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects |
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| Completed | 1 | 84 | Europe | E5501 40 mg 2 x 20-mg tablets, orally, fasted, E5501 40 mg 2 x 20-mg tablets, orally, with food, E5501 40mg 2 x 20-mg tablets, orally, fasted | Eisai Inc. | Purpura, Thrombocytopenic, Idiopathic, Acute Idiopathic Thrombocytopenic Purpura, Chronic Thrombocytopenia | 04/11 | 06/11 | | |
NCT01437384: Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects Comparing the Interactions Between E5501 and Verapamil and Cyclosporine. |
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| Completed | 1 | 36 | US | E5501 | Eisai Inc. | Idiopathic Thrombocytopenic Purpura (ITP) | 03/12 | | | |
NCT01549054: A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501 |
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| Completed | 1 | 28 | Europe | 10-mg dose of E5501 2G tablet, 10-mg dose of E5501 cyclodextrin oral solution, 10-mg dose of E5501-P21% powder, 10-mg dose of E5501 lipid-based oral | Eisai Inc. | Idiopathic Thrombocytopenic Purpura | 06/12 | 08/12 | | |
NCT01759394: A Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal |
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| Completed | 1 | 36 | US | Avatrombopag maleate 40 mg, E5501 | Eisai Inc. | Healthy Volunteers | 01/13 | 03/13 | | |
NCT01774773: A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet (Study E5501-J081-015) |
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| Completed | 1 | 15 | Japan | Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg, Group B: E5501 20mg, then 40mg, then 5 mg, then 5mg, Group C: E5501 40mg, then 5mg, then 20 mg, then 5mg | Eisai Co., Ltd. | Healthy | 07/13 | 08/13 | | |
NCT02039076: A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects |
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| Completed | 1 | 48 | US | avatrombopag | Eisai Inc. | Thrombocytopenia | 06/14 | 09/14 | | |
NCT02809768: Study to Assess Pharmacokinetic Drug-Drug Interaction Between Avatrombopag When Co-Administered With Fluconazole, Itraconazole, or Rifampin in Healthy Subjects |
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| Completed | 1 | 48 | US | Avatrombopag, E5501, Fluconazole, Itraconazole, Rifampin | Eisai Inc. | Healthy Participants | 08/16 | 09/16 | | |
| Recruiting | 1 | 24 | US | Avatrombopag | University of Rochester | Thrombocytopenia | 09/24 | 09/24 | | |