Status:
COMPLETED
A Study of Fostamatinib in Subjects With Impaired Kidney Function
Lead Sponsor:
AstraZeneca
Conditions:
Rheumatoid Arthritis
Renal Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01245790
Start Date
November 1 2010
End Date
June 1 2011
Last Update
June 16 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Orlando, Florida, United States