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

NCT ID: NCT01608542

Last Updated: 2012-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-08-31

Brief Summary

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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

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

Conditions

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Healthy Japanese Volunteers

Keywords

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fostamatinib FosD Japanese Healthy volunteers Phase 1 Single and Multiple Dose Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fostamatinib 100mg

Up to two cohorts of Japanese subjects are planned to receive fostamatinib 100mg single and multiple twice daily doses

Group Type EXPERIMENTAL

Fostamatinib 100mg

Intervention Type DRUG

oral tablet

Fostamatinib 200mg

Up to two cohorts of Japanese subjects are planned to receive fostamatinib 200mg single and multiple twice daily doses

Group Type EXPERIMENTAL

Fostamatinib 200mg

Intervention Type DRUG

oral tablet

Interventions

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Fostamatinib 100mg

oral tablet

Intervention Type DRUG

Fostamatinib 200mg

oral tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Layton, MD

Role: STUDY_DIRECTOR

AstraZeneca

David Han, MD

Role: PRINCIPAL_INVESTIGATOR

PAREXEL Early Phase/California Clinical Trials Medical Group

Locations

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Glendale, California, United States

Site Status

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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D4300C00032

Identifier Type: -

Identifier Source: org_study_id