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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Fostamatinib Disodium in Healthy Japanese and White Subjects After Single and Multiple Ascending Doses

Conditions
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Healthy

Intervention / Treatment
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* Drug: FosD
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FosD<br>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 | Drug: FosD<br>* oral tablet<br>|
| Placebo Comparator: Placebo<br>Placebo given (2 subjects in each cohort) | Drug: Placebo<br>* oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fostamatinib disodium, FosD, Japanese, Healthy volunteers, Phase 1, Single and Multiple Ascending Dose Study, Healthy Japanese volunteers, Healthy White volunteers