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