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A 2 stage study to evaluate the amount of fostamatinib in the blood and urine in subjects with impaired kidney (renal) function compared with healthy volunteers with normal renal function. Stage 1 will include healthy subjects and subjects with end stage renal disease, while Stage, 2 may include subjects with mild, moderate and/or severe renal impairment dependent on the outcome of Stage 1. The study will also evaluate safety and tolerability in subjects with renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Healthy subjects (Stage 1) |
|
| 2 | Experimental | Mild renal impairment (Stage 2) |
|
| 3 | Experimental | Moderate renal impairment (Stage 2) |
|
| 4 | Experimental | Severe renal impairment (Stage 2) |
|
| 5 | Experimental | End stage renal disease (Stage 1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fostamatinib | Drug | Oral tablets, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetic (PK) parameters | Parameters include: AUC, Cmax |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability variables of fostamatinib 150mg: Adverse events, vital signs, physical examinations, clinical laboratory tests and electrocardiograms | ||
| Urine PK parameters of R406 and its N-glucuronide metabolite | PK parameters including but not limited to Amount excreted (Ae) and renal clearance (CLr) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Layton, MD | AstraZeneca | Study Director |
| Thomas Marbury, MD | Orlando Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Orlando | Florida | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26519231 | Derived | Martin P, Oliver S, Gillen M, Marbury T, Millson D. Pharmacokinetic Properties of Fostamatinib in Patients With Renal or Hepatic Impairment: Results From 2 Phase I Clinical Studies. Clin Ther. 2015 Dec 1;37(12):2823-36. doi: 10.1016/j.clinthera.2015.09.016. Epub 2015 Oct 27. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C523665 | fostamatinib |
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| The effects of differences in protein binding by assessment of unbound R406 PK | PK parameters including, but not limited to, unbound AUC and unbound Cmaxt |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |