A Study of Fostamatinib in Subjects With Impaired Kidney Function

Rheumatoid Arthritis Clinical Trial

Official title:

An Open-label, Phase I Study to Assess the Pharmacokinetics of R406 in Subjects With Renal Impairment Compared to Healthy Subjects Following Administration of a Single Dose of Fostamatinib 150 mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245790
• Other study ID #: D4300C00009
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2010
• Last updated: June 15, 2011
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Renal Impairment
• Renal Insufficiency
• Rheumatoid Arthritis

Intervention

Drug:
• fostamatinib
Oral tablets, single dose

Locations

Country	Name	City	State
United States	Research Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma pharmacokinetic (PK) parameters	Parameters include: AUC, Cmax		No
Secondary	Safety and tolerability variables of fostamatinib 150mg: Adverse events, vital signs, physical examinations, clinical laboratory tests and electrocardiograms			Yes
Secondary	Urine PK parameters of R406 and its N-glucuronide metabolite	PK parameters including but not limited to Amount excreted (Ae) and renal clearance (CLr)		No
Secondary	The effects of differences in protein binding by assessment of unbound R406 PK	PK parameters including, but not limited to, unbound AUC and unbound Cmaxt		No

External Links

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