Effects of administration of fostamatinib on blood concentrations of digoxin in healthy subjects
Study identifier:D4300C00026
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open-Label, Non-Randomised, 2-Period, Single Centre Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects when Administered Alone and in Combination with Fostamatinib 100 mg Twice Daily
Medical condition
Healthy Volunteers, Rheumatoid Arthritis
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Digoxin, Fostamatinib
Sex
All
Actual Enrollment
21
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Jun 2011
Primary Completion Date: 01 Sept 2011
Study Completion Date: 01 Sept 2011
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Jan 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Digoxin | Drug: Digoxin oral tablets, 0.25mg bd on Day 1 and 0.25 Once daily from Day 2 to 15 |
| Experimental: 2 Fostamatinib | Drug: Digoxin oral tablets, 0.25mg bd on Day 1 and 0.25 Once daily from Day 2 to 15 Drug: Fostamatinib oral tablets, 100mg (2 X 50mg) bd from Day 9 - 15 |
