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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 |
|---|---|---|---|
| A | Experimental | Fostamatinib 50 mg tablet x 2 (Phase 3 batch) |
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| B | Sham Comparator | Fostamatinib 50 mg tablet x 3 (Phase 3 batch) |
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| C | Experimental | Fostamatinib 100 mg tablet (new formulation) |
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| D | Experimental | Fostamatinib 150 mg tablet (new formulation) |
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| E | Experimental | Fostamatinib 50 mg tablet x 2 (Phase 3 batch) |
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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 |
|---|---|---|
| To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 100-mg tablet versus 2 x 50-mg tablets (Phase III formulation) | Assessments will include but is not limited to: plasma R406 AUC, Cmax | From Pre-dose until 96 hours post dose of each treatment period |
| To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 150-mg tablet versus 3 x 50-mg tablets (Phase III formulation) | Assessments will include but is not limited to: plasma R406 AUC, Cmax ) | From pre-dose until 96 hours post dose of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| To examine the safety and tolerability of fostamatinib 50 mg, 100 mg, and 150 mg tablet batches | The safety endpoints will include adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs. | From pre-dose until 96 hours post dose of each treatment period |
| To estimate the within subject variability in R406 exposure when fostamatinib 50 mg tablets are administered on 2 separate occasions. |
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Inclusion Criteria:
Exclusion Criteria:
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| 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, 50 mg x 3, single dose |
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| Fostamatinib | Drug | Oral tablets, 100 mg, single dose |
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| Fostamatinib | Drug | Oral tablets, 150 mg, single dose |
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| Fostamatinib | Drug | Oral tablets, 50 mg x 2, single dose |
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Assessments will include but is not limited to: plasma R406 plasma AUC0-t, t1/2, and tmax |
| From pre-dose until 96 hours post dose of each treatment period |