A Study of Fostamatinib in Subjects With Impaired Kidney Function

Completed · Phase 1

Conditions studied: Rheumatoid Arthritis, Renal Impairment

In brief

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.

Key facts

Study ID

NCT01245790

Run by

AstraZeneca

People needed

24

Starts

2010-11-01

Expected to finish

2011-06-01

Last updated by the study team

2011-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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