A Single and Multiple Dose Study to Assess Blood and Urine Drug Levels of Fostamatinib in Healthy Japanese Subjects

Completed · Phase 1

Conditions studied: Healthy Japanese Volunteers

In brief

This is a single and multiple dose study in healthy male and female (of non-child bearing potential) Japanese volunteers, to assess the blood and urine drug levels of Fostamatinib. Fostamatinib is being developed for the treatment of rheumatoid arthritis.

Key facts

Study ID

NCT01608542

Run by

AstraZeneca

People needed

24

Starts

2012-06-01

Expected to finish

2012-08-01

Last updated by the study team

2012-12-19

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
• 20 to 45 years of age
• 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
• Previous participation in a fostamatinib study

Where it is running

• Study site — Glendale, California, United States
• Study site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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