A study to assess the safety, tolerability, and blood and urine drug levels of fostamatinib disodium (FosD) in healthy Japanese and White subjects
Study identifier:D4300C00007
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Fostamatinib disodium in Healthy Japanese and White Subjects After Single and Multiple Ascending Doses
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
FosD, Placebo
Sex
All
Actual Enrollment
56
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Jul 2010
Primary Completion Date: 01 May 2011
Study Completion Date: 01 May 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: FosD Four sequential cohorts of Japanese subjects are planned with doses ranging from 50mg once daily to a maximum of 200mg twice daily. One cohort of White subjects is also planned to receive the same dose regimen as the third dose level in Japanese subjects | Drug: FosD oral tablet |
| Placebo Comparator: Placebo Placebo given (2 subjects in each cohort) | Drug: Placebo oral tablet |
Contacts
Investigators
Principal Investigator
Mark Layton
AstraZeneca
