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Study in Healthy Males to Assess Bioavailability of Single Fostamatinib With iv Micro Tracer Dose

NCT ID: NCT01598571

Last Updated: 2012-08-22

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-08-31

Brief Summary

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Study in healthy males to assess bioavailability of single fostamatinib with iv micro tracer dose.

Detailed Description

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A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib with Respect to an Intravenous Micro Tracer Dose of \[14C\] R406 in Healthy Male Volunteers.

Conditions

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Healthy

Keywords

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Phase 1 Healthy male volunteers pharmacokinetics fostamatinib Bioavailability R406 plasma AUC and Cmax R406 plasma AUC0-t t1/2λz tmax

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fostamatinib 50 mg tablet

Group Type EXPERIMENTAL

Fostamatinib

Intervention Type DRUG

Fostamatinib 50 mg tablet

Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose

Group Type EXPERIMENTAL

Fostamatinib

Intervention Type DRUG

Fostamatinib 100 μg \[14C\] R406 intravenous micro tracer dose

Interventions

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Fostamatinib

Fostamatinib 50 mg tablet

Intervention Type DRUG

Fostamatinib

Fostamatinib 100 μg \[14C\] R406 intravenous micro tracer dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers aged 18 to 55 years (inclusive), with a weight of at least 50 kg and a body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
* Male volunteers willing to use barrier contraception ie, condoms with spermicide, from the first day of the investigational product administration until 3 months after the last administration of the investigational product

Exclusion Criteria

* History of any clinically significant disease or disorder
* History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of drug
* Volunteers who smoke more than 5 cigarettes or the equivalent in tobacco per day
* Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results as judged by the Investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

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, Alderley Park

Sharan Sidhu, MB CHB, BAO, MRCS

Role: PRINCIPAL_INVESTIGATOR

Quotient Clinical Unit

Locations

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Ruddington, Nottingham, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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QBR112696

Identifier Type: -

Identifier Source: secondary_id

D4300C00027

Identifier Type: -

Identifier Source: org_study_id