Study identifier:D4300C00010
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
An Open-label, Single-center Study to Assess the Pharmacokinetics of R406 in Subjects with Hepatic Impairment and in Healthy Subjects Following Administration of a Single Dose of Fostamatinib Disodium 150 mg
Hepatic Impairment, Healthy Volunteers, Amount of R406 in blood
Phase 1
Yes
Fostamatinib
All
32
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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A study to evaluate the amount of fostamatinib in the blood in subjects with impaired hepatic (liver) function compared with healthy volunteers with normal liver function. The study will also evaluate safety and tolerability in subjects with hepatic impairment.
Location
Location
ORLANDO, FL, United States
Arms | Assigned Interventions |
---|---|
Experimental: 1 Mild hepatic impairment | Drug: Fostamatinib Oral tablets, single dose |
Experimental: 2 Moderate hepatic impairment | Drug: Fostamatinib Oral tablets, single dose |
Experimental: 3 Severe hepatic impairment | Drug: Fostamatinib Oral tablets, single dose |
Experimental: 4 Matched healthy volunteers with normal hepatic function | Drug: Fostamatinib Oral tablets, single dose |
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