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Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin in Healthy Subjects

NCT ID: NCT01311622

Last Updated: 2013-01-31

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to determine whether fostamatinib influences the plasma concentration of warfarin and changes its blood thinning effect, and to investigate how safe and tolerable it is when administered with warfarin.

Detailed Description

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Conditions

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Rheumatoid Arthritis Healthy Subjects

Keywords

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drug-drug interaction Phase 1 healthy subjects warfarin Rheumatoid arthritis RA fostamatinib open-label pharmacokinetics pharmacodynamics level of Warfarin in the blood

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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warfarin

Group Type EXPERIMENTAL

warfarin

Intervention Type DRUG

2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart

warfarin and fostamatinib

Group Type EXPERIMENTAL

warfarin

Intervention Type DRUG

2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart

fostamatinib

Intervention Type DRUG

2 x 50 mg Fostamatinib tablets (100 mg) twice daily for 13 days

Interventions

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warfarin

2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart

Intervention Type DRUG

fostamatinib

2 x 50 mg Fostamatinib tablets (100 mg) twice daily for 13 days

Intervention Type DRUG

Other Intervention Names

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Marevan

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures (including genotyping screening sample for CYP2C9 and VKORC1).
* Males or females (of non-childbearing potential) aged 18 to 55 years (inclusive)
* Subjects must be negative for occult blood (stool card) prior to administration.
* Body weight of at least 50 kg and body mass index (BMI) between 18 and 35 kg/m2 inclusive

Exclusion Criteria

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, or influence the results of the study.
* Healthy subject predicted to be most sensitive to warfarin based on CYP2C9 and VKORC1 genotypes.
* A protein C and/or protein S deficiency.
* Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
* Previous treatment with warfarin for a clinical indication (ie, participation in a previous warfarin interaction study is acceptable).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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James Ritter, BM BCh MRCP FRCP

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Phase 1 Unit, London

Mark Layton, MD MRCP (UK)

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D4300C00013

Identifier Type: -

Identifier Source: org_study_id