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A study to evaluate the amount of fostamatinib in the blood in subjects with impaired hepatic (liver) function compared with healthy volunteers with normal liver function. The study will also evaluate safety and tolerability in subjects with hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Mild hepatic impairment |
|
| 2 | Experimental | Moderate hepatic impairment |
|
| 3 | Experimental | Severe hepatic impairment |
|
| 4 | Experimental | Matched healthy volunteers with normal hepatic function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fostamatinib | Drug | Oral tablets, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine plasma PK parameters of R406 in subjects with varying degrees of hepatic impairment as well as in healthy subjects (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2)) | From pre-dose until 120 hours after the single dose |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate safety and tolerability of fostamatinib 150mg: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs. | From pre-dose until 120 hours after the single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Marbury, MD | Orlando Clinical Research Center | 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. |
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| ID | Term |
|---|---|
| C523665 | fostamatinib |
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