A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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 drug levels of FosD. FosD is being developed for the treatment of rheumatoid arthritis.

Key facts

Study ID

NCT01167868

Run by

AstraZeneca

People needed

56

Starts

2010-07-01

Expected to finish

2011-05-01

Last updated by the study team

2013-02-07

Who can join

Age: 20 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Glendale, California, United States

Full record on ClinicalTrials.gov

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