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

Phase 1

Completed

• Conditions: Healthy Japanese Volunteers
• Interventions: Drug: Fostamatinib 100mg; Drug: Fostamatinib 200mg

• Registration Number: NCT01608542
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-05-30
• Study First Posted: 2012-05-31
• Study Start: 2012-06
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-18
• Last Update Posted: 2012-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fostamatinib 100mg	Fostamatinib 100mg	Up to two cohorts of Japanese subjects are planned to receive fostamatinib 100mg single and multiple twice daily doses
Fostamatinib 200mg	Fostamatinib 200mg	Up to two cohorts of Japanese subjects are planned to receive fostamatinib 200mg single and multiple twice daily doses

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) profile of fostamatinib from blood and urine in terms of AUC; tmax; Cmax; t1/2 and Rac.	PK sampling at predose, 0, 0.25, 0.5, 1,1.5, 2, 4, 6, 8,12, 16, 24, 36, 48 and 72 hours post-dose following the single dose (on Day 1) and after repeated twice daily dosing on Days 4 and 10	AUC - area under the plasma concentration time curve from zero to infinity ; tmax - time to max plasma concentration; t1/2 - terminal elimination half life; Rac - accumulation ratio

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability profile in terms of adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, 12 lead ECG	Up to Day 20