Doptelet (avatrombopag) / SOBI  >>  Phase 1
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11 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
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

Completed
1
16
US
E5501
Eisai Inc.
Healthy Subjects
06/10
06/10
NCT01251731: Single and Multiple Dose Asian Bridging Study

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

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

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.

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

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

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)

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

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

Completed
1
48
US
Avatrombopag, E5501, Fluconazole, Itraconazole, Rifampin
Eisai Inc.
Healthy Participants
08/16
09/16
APATIT-G, NCT04931849: Study of Avatrombopag for Temozolomide-induced Thrombocytopenia in Glioma

Recruiting
1
24
US
Avatrombopag
University of Rochester
Thrombocytopenia
09/24
09/24

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