NCT01245790

A Study of Fostamatinib in Subjects With Impaired Kidney Function

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rheumatoid Arthritis
• Renal Impairment

Interventions

Type	Name	Description
DRUG	fostamatinib	Oral tablets, single dose

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-11-23
• Last updated: 2011-06-16

Locations

1 site across 1 country: United States