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Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability

NCT ID: NCT01682408

Last Updated: 2012-12-28

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-12-31

Brief Summary

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Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets

Detailed Description

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An Open-label, Single-center, 2-Part, Randomized Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets

Conditions

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Pharmacokinetics

Keywords

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R406, Fostamatinib, Phase I, Healthy Subjects, Pharmacokinetics, Fed/Fasted

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part A1

1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), fed 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed

Group Type ACTIVE_COMPARATOR

Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)

Intervention Type DRUG

1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)

Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed

Intervention Type DRUG

3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed

Part A2

1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed 150 mg ranitidine

Group Type ACTIVE_COMPARATOR

Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)

Intervention Type DRUG

1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)

Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed

Intervention Type DRUG

3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed

Ranitidine

Intervention Type DRUG

150 mg ranitidine

Part B1

1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)

Group Type ACTIVE_COMPARATOR

Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)

Intervention Type DRUG

1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)

Part B2

1 x 150mg mannitol based 38% drug loaded tablet (batch variant B)

Group Type ACTIVE_COMPARATOR

Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B)

Intervention Type DRUG

1 x 150mg mannitol based 38% drug loaded tablet(batch variant B)

Part B3

1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)

Group Type ACTIVE_COMPARATOR

Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)

Intervention Type DRUG

1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)

Interventions

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Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)

1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)

Intervention Type DRUG

Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed

3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed

Intervention Type DRUG

Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)

1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)

Intervention Type DRUG

Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B)

1 x 150mg mannitol based 38% drug loaded tablet(batch variant B)

Intervention Type DRUG

Ranitidine

150 mg ranitidine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated, written informed consent prior to any study-specific procedures including the genetic sampling and analyses
* Volunteers will be males or females aged 18 to 55 years (inclusive) and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive.
* Provision of signed, written, and dated informed consent for optional genetic research. If a volunteer declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the volunteer.
* Male volunteers should be willing to use barrier contraception, ie, condoms from the day of first dosing until 2 weeks after dosing with the IP in Treatment Period 5.
* Females must have a negative pregnancy test at screening and on admission to the CPU (including check-in at each treatment period), must not be lactating and must be of non childbearing potential, confirmed at screening

Exclusion Criteria

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
* 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 IP
* Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV)
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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Eleanor Lisbon, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles Phase I unit 6700 w 115th st Overland Park, Ks 66211

Christopher D O'Brien, MD PHD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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D4300C00019

Identifier Type: -

Identifier Source: org_study_id