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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: FosD; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01167868

D4300C00007

Details and patient eligibility

About

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.

Enrollment: 56 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 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 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

FosD

Experimental group

Description:

Four sequential cohorts of Japanese subjects are planned with doses ranging from 50mg once daily to a maximum of 200mg twice daily. One cohort of White subjects is also planned to receive the same dose regimen as the third dose level in Japanese subjects

Treatment:

Drug: FosD

Placebo

Placebo Comparator group

Description:

Placebo given (2 subjects in each cohort)

Treatment:

Drug: Placebo