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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: FosD; Drug: Placebo

• Registration Number: NCT01167868
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FosD	FosD	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
Placebo	Placebo	Placebo given (2 subjects in each cohort)

Primary Outcome Measures

Name	Time	Method
To investigate safety and tolerability: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, 12 lead ECG, digital ECG, telemetry.	Prior to treatment, during treatment, and a follow-up visit, a total of up to 20 days

Secondary Outcome Measures

Name	Time	Method
To determine plasma PK parameters (including but not limited to: AUC, tmax, Cmax, terminal elimination half life (t1/2) and accumulation ratio (Rac)) of FosD.	Plasma sampling for 72 hours following both the single dose and after 7 days repeated dosing.
To determine urine PK parameters (including but not limited to: amount excreted (Ae) and renal clearance (CLr)) of FosD.	Urine sampling for upto 48 hours following both the single dose and after 7 days repeated dosing.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Glendale, California, United States