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The purpose of this study is to determine whether fostamatinib influences the plasma concentration of warfarin and changes its blood thinning effect, and to investigate how safe and tolerable it is when administered with warfarin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| warfarin | Experimental |
| |
| warfarin and fostamatinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| warfarin | Drug | 2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine PK parameters of R- and S-warfarin including but not limited to AUC and Cmax |
| From pre-dose to 168 h post dose relative to each single warfarin dose |
| Measure | Description | Time Frame |
|---|---|---|
| To measure International Normalised Ratio (INR) following administration of warfarin | From pre-dose to 168 h post dose relative to each single warfarin dose | |
| To assess the steady-state pharmacokinetics of R406 (active metabolite of fostamatinib) by measuring AUCss, Cmax,ss, tmax,ss and CL/F |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Ritter, BM BCh MRCP FRCP | Quintiles, Phase 1 Unit, London | Principal Investigator |
| Mark Layton, MD MRCP (UK) | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| C523665 | fostamatinib |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| fostamatinib | Drug | 2 x 50 mg Fostamatinib tablets (100 mg) twice daily for 13 days |
|
| From predose on Day 11 until 12 h post dose on Day 14 relative to fostamatinib dosing |
| Safety and tolerability will be measured with regard to adverse events, laboratory assessments, vital signs, physical examination, and 12-lead ECG will be recorded. | To examine the safety and tolerability of fostamatinib in combination with Warfarin: Adverse events, laboratory assessments, vital signs, physical examination, and 12-lead ECG | From screening, Day -1 to Day 21 and follow up visit (Day 28) |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |