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The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Fostamatinib |
|
| 2 | Experimental | Rifampicin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fostamatinib | Drug | oral tablets, 150mg (3 X 50mg) single dose per period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured | Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC (0-t), terminal half life, and tmax will be measured | Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose | |
| To examine the safety and tolerability of fostamatinib in combination with rifampicin. |
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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 |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C523665 | fostamatinib |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| rifampicin |
| Drug |
oral tablets, 600mg (2 X 300mg) 8 doses over 8 days |
|
Assessments include: Adverse events, laboratory assessments, vital signs, physical examination and 12-lead electrocardiogram. Absolute values and change in baseline for any of these parameters will be reported. |
| From screening, Day 1 - Day 25, up to follow up visit |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |