A Study of Fostamatinib in Subjects With Impaired Hepatic (Liver) Function

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Single-center Study to Assess the Pharmacokinetics of R406 in Subjects With Hepatic Impairment and in Healthy Subjects Following Administration of a Single Dose of Fostamatinib Disodium 150 mg

Conditions
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Hepatic Impairment, Healthy Volunteers, Pharmacokinetics, Amount of R406 in Blood

Intervention / Treatment
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* Drug: Fostamatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females (non child-bearing potential) aged 18 years or more, with a weight of at least 50 kg and body mass index (BMI) between 18 and 40 kg/m2 inclusive Healthy subjects only: good health as determined by a medical history, physical examination , ECG and clinical laboratory evaluations Healthy subjects only: negative results for serum hepatitis B and C Exclusion Criteria: Subjects who have received any medications known to alter drug absorption or elimination within 30 days of first dose. Subjects who smoke more than 10 cigarettes or equivalent per day Absolute neutrophil count <2500/mm3 Abnormal vital signs, additional systemic disease (eg, cardiac, or renal disease) or abnormal laboratory findings that are judged to be clinically significant by the investigator Healthy volunteers only: use of prescribed medications within 2 weeks of first dose or use of non-prescribed medications within 1 week of first dose Hepatic subjects only: fluctuating or rapidly deteriorating hepatic function

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Mild hepatic impairment | Drug: Fostamatinib<br>* Oral tablets, single dose<br>|
| Experimental: 2<br>Moderate hepatic impairment | Drug: Fostamatinib<br>* Oral tablets, single dose<br>|
| Experimental: 3<br>Severe hepatic impairment | Drug: Fostamatinib<br>* Oral tablets, single dose<br>|
| Experimental: 4<br>Matched healthy volunteers with normal hepatic function | Drug: Fostamatinib<br>* Oral tablets, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Healthy volunteers, Volunteers with hepatic impairment, Pharmacokinetics, Fostamatinib