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This is a single and multiple dose study in healthy male and female (of non-child bearing potential) Japanese volunteers, to assess the blood and urine drug levels of Fostamatinib. Fostamatinib is being developed for the treatment of rheumatoid arthritis.
A Phase I, Open-label Study to Assess the Pharmacokinetics of Oral Fostamatinib in Healthy Japanese Subjects After Single and Multiple Doses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fostamatinib 100mg | Experimental | Up to two cohorts of Japanese subjects are planned to receive fostamatinib 100mg single and multiple twice daily doses |
|
| Fostamatinib 200mg | Experimental | Up to two cohorts of Japanese subjects are planned to receive fostamatinib 200mg single and multiple twice daily doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fostamatinib 100mg | Drug | oral tablet |
| |
| Fostamatinib 200mg |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile of fostamatinib from blood and urine in terms of AUC; tmax; Cmax; t1/2 and Rac. | AUC - area under the plasma concentration time curve from zero to infinity ; tmax - time to max plasma concentration; t1/2 - terminal elimination half life; Rac - accumulation ratio | PK sampling at predose, 0, 0.25, 0.5, 1,1.5, 2, 4, 6, 8,12, 16, 24, 36, 48 and 72 hours post-dose following the single dose (on Day 1) and after repeated twice daily dosing on Days 4 and 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability profile in terms of adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, 12 lead ECG | Up to Day 20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Layton, MD | AstraZeneca | Study Director |
| David Han, MD | PAREXEL Early Phase/California Clinical Trials Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | California | United States | ||||
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| ID | Term |
|---|---|
| C523665 | fostamatinib |
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| Drug |
oral tablet |
|
| Baltimore |
| Maryland |
| United States |