Effects of administration of fostamatinib on blood concentrations of warfarin in healthy subjects
Study identifier:D4300C00013
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open-Label, Single Centre Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin when Co-Administered with Fostamatinib in Healthy Subjects
Medical condition
Rheumatoid Arthritis, Healthy subjects
Phase
Phase 1
Healthy volunteers
Yes
Study drug
warfarin, fostamatinib
Sex
All
Actual Enrollment
15
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Mar 2011
Primary Completion Date: 01 May 2011
Study Completion Date: 01 May 2011
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Apr 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: warfarin | Drug: warfarin 2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart Other Name: Marevan |
| Experimental: warfarin and fostamatinib | Drug: warfarin 2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart Other Name: Marevan Drug: fostamatinib 2 x 50 mg Fostamatinib tablets (100 mg) twice daily for 13 days |
Contacts
Investigators
Principal Investigator
James Ritter
Quintiles, Phase 1 Unit, London
