A Study of Fostamatinib in Subjects With Impaired Kidney Function

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Renal Impairment; Rheumatoid Arthritis

Treatments: Drug: fostamatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01245790

D4300C00009

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males or females (non child bearing potential) greater than or equal to 18 years of age with suitable veins for cannulation or repeated venipuncture and with a weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 40 kg/m2, inclusive
• Stable renal impairment with following creatinine clearance (CLCR): Stage 1 - End Stage Renal Disease (ESRD) < 15 mL/min (requiring dialysis); Stage 2 - Mild renal impairment ≥ 50 to < 80 mL/min; Moderate renal impairment ≥ 30 to <50 mL/min; and severe renal impairment 15 to < 30 mL/min
• Healthy subjects with normal renal function must have good health based on medical history, physical examination , echocardiogram and clinical laboratory evaluations including creatinine clearance >80 ml/min"
• Negative screen for Human Immunodeficiency Virus and negative results for serum hepatitis B surface antigen and hepatitis C antibody

Exclusion criteria

• Subjects who have received any medications known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration
• Absolute neutrophil count less than 1600/mm3 or 1.6 x 109 L.
• Healthy subjects only: Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration
• Subjects with a history of multiple drug allergies or with a known allergy to the drug class of fostamatinib
• In the opinion of the Investigator, any evidence of additional severe or uncontrolled systemic disease (eg, currently unstable or uncompensated hepatic, cardiovascular, or respiratory disease) or laboratory finding

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 5 patient groups

1

Experimental group

Description:

Healthy subjects (Stage 1)

Treatment:

Drug: fostamatinib

2

Experimental group

Description:

Mild renal impairment (Stage 2)

Treatment:

Drug: fostamatinib

3

Experimental group

Description:

Moderate renal impairment (Stage 2)

Treatment:

Drug: fostamatinib

4

Experimental group

Description:

Severe renal impairment (Stage 2)

Treatment:

Drug: fostamatinib

5

Experimental group

Description:

End stage renal disease (Stage 1)

Treatment:

Drug: fostamatinib