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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy Japanese Volunteers

Treatments

Drug: Fostamatinib 200mg

Drug: Fostamatinib 100mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01608542

D4300C00032

Details and patient eligibility

About

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.

Full description

A Phase I, Open-label Study to Assess the Pharmacokinetics of Oral Fostamatinib in Healthy Japanese Subjects After Single and Multiple Doses

Enrollment

24 patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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