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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01167868

Enrollment

Registered

2010-07-22

Start date

2010-07-31

Completion date

2011-05-31

Last updated

2013-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

fostamatinib disodium, FosD, Japanese, Healthy volunteers, Phase 1, Single and Multiple Ascending Dose Study, Healthy Japanese volunteers, Healthy White volunteers

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.

Interventions

DRUGFosD

oral tablet

DRUGPlacebo

oral tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026