Study identifier:D4300C00009
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Rheumatoid Arthritis, Renal Impairment
Phase 1
Yes
fostamatinib
All
24
Interventional
18 Years +
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Apr 2014 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 1 Healthy subjects (Stage 1) | Drug: fostamatinib Oral tablets, single dose |
Experimental: 2 Mild renal impairment (Stage 2) | Drug: fostamatinib Oral tablets, single dose |
Experimental: 3 Moderate renal impairment (Stage 2) | Drug: fostamatinib Oral tablets, single dose |
Experimental: 4 Severe renal impairment (Stage 2) | Drug: fostamatinib Oral tablets, single dose |
Experimental: 5 End stage renal disease (Stage 1) | Drug: fostamatinib Oral tablets, single dose |