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Study in healthy males to assess bioavailability of 4 different fostamatinib tablets
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Fostamatinib 50 mg tablet x 2 |
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| 2 | Experimental | Fostamatinib 100 mg tablet (batch 1) |
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| 3 | Experimental | Fostamatinib 100 mg tablet (batch 2) |
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| 4 | Experimental | Fostamatinib 100 mg tablet (batch 4) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fostamatinib | Drug | Oral tablets, 50 mg x 2, single dose |
| |
| Fostamatinib |
| Measure | Description | Time Frame |
|---|---|---|
| Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax ) | Daily during Treatment Period 1 until 96 hours post dose of each treatment period | |
| Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax ) | Daily during Treatment Period 2 until 96 hours post dose of each treatment period | |
| Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax ) | Daily during Treatment Period 3 until 96 hours post dose of each treatment period | |
| Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax ) | Daily during Treatment Period 4 until 96 hours post dose of each treatment period | |
| Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax ) | Daily during Treatment Period 1 until 96 hours post dose of each treatment period | |
| Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax ) | Daily during Treatment Period 2 until 96 hours post dose of each treatment period | |
| Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax ) |
| Measure | Description | Time Frame |
|---|---|---|
| To examine the safety and tolerability of fostamatinib 50 mg and 100 mg tablet batches The safety endpoints will include: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs. | Screening, throughout the 4 treatment periods, and follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Layton, MD | AstraZeneca | Study Director |
| Carlos Prendes, MD | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
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| ID | Term |
|---|---|
| C523665 | fostamatinib |
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| Drug |
Oral tablets, 100 mg Batch 1, single dose |
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| Fostamatinib | Drug | Oral tablets, 100 mg Batch 2, single dose |
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| Fostamatinib | Drug | Oral tablets, 100 mg Batch 3, single dose |
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| Daily during Treatment Period 3 until 96 hours post dose of each treatment period |
| Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax ) | Daily during Treatment Period 4 until 96 hours post dose of each treatment period |