Status:
COMPLETED
A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
This is a single and multiple ascending dose study in healthy male and female (of non-child bearing potential) Japanese and White volunteers, to assess the safety, tolerability, and blood and urine dr...
Eligibility Criteria
Inclusion
- Healthy male and female (of non-childbearing potential) Japanese subjects and White subjects (origins in Europe, the Middle East, or North Africa)
- Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 45 kg and no more than 100 kg
Exclusion
- History or presence of respiratory, GI, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
- Any clinically significant illness, acute infection, known inflammatory process, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
- Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1
- Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01167868
Start Date
July 1 2010
End Date
May 1 2011
Last Update
February 7 2013
Active Locations (1)
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1
Research Site
Glendale, California, United States