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Study in Healthy Males to Assess the Bioavailability of 4 Different Fostamatinib Tablets

NCT ID: NCT01387308

Last Updated: 2011-10-28

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

2011-08-31

Study Completion Date

2011-10-31

Brief Summary

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Study in healthy males to assess bioavailability of 4 different fostamatinib tablets.

Detailed Description

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Conditions

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Healthy

Keywords

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Phase 1 Healthy male volunteers pharmacokinetics fostamatinib Scientific Terminology: Bioavailability, R406 plasma AUC and C_maxR406 plasma AUC0-t, t1/2λz and t_max Laymen Terminology: Amount of R406 in blood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

Fostamatinib 50 mg tablet x 2 (Phase 3 batch)

Group Type EXPERIMENTAL

Fostamatinib

Intervention Type DRUG

Oral tablets, 50 mg x 2, single dose

B

Fostamatinib 50 mg tablet x 3 (Phase 3 batch)

Group Type SHAM_COMPARATOR

Fostamatinib

Intervention Type DRUG

Oral tablets, 50 mg x 3, single dose

C

Fostamatinib 100 mg tablet (new formulation)

Group Type EXPERIMENTAL

Fostamatinib

Intervention Type DRUG

Oral tablets, 100 mg, single dose

D

Fostamatinib 150 mg tablet (new formulation)

Group Type EXPERIMENTAL

Fostamatinib

Intervention Type DRUG

Oral tablets, 150 mg, single dose

E

Fostamatinib 50 mg tablet x 2 (Phase 3 batch)

Group Type EXPERIMENTAL

Fostamatinib

Intervention Type DRUG

Oral tablets, 50 mg x 2, single dose

Interventions

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Fostamatinib

Oral tablets, 50 mg x 2, single dose

Intervention Type DRUG

Fostamatinib

Oral tablets, 50 mg x 3, single dose

Intervention Type DRUG

Fostamatinib

Oral tablets, 100 mg, single dose

Intervention Type DRUG

Fostamatinib

Oral tablets, 150 mg, single dose

Intervention Type DRUG

Fostamatinib

Oral tablets, 50 mg x 2, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated informed consent prior to any study specific procedures
* Volunteers will be males aged 18 to 55 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive
* Volunteers agreeing to participate in the optional genetic research must provide a separate, signed, written and dated informed consent for genetic research. The volunteer will not be excluded from other aspects of the study described in this Clinical Study Protocol so long as they consent to them

Exclusion Criteria

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, 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 investigational product
* Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
* Any clinically significant abnormalities in clinical chemistry, haematology 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

Locations

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Research Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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D4300C00018

Identifier Type: -

Identifier Source: org_study_id