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

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 investigate the drug interaction between fostamatinib and pioglitazone by comparing the safety, tolerability and plasma concentration of pioglitazone when administered alone and with fostamatinib in healthy subjects.

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Detailed Description

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Conditions

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Rheumatoid Arthritis Healthy Volunteers Pharmacokinetics Pioglitazone Drug-drug Interaction Amount of Pioglitazone in 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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pioglitazone

Group Type EXPERIMENTAL

fostamatinib

Intervention Type DRUG

oral tablets, 100mg (2 X 50mg) twice daily for 8 days

pioglitazone

Intervention Type DRUG

oral tablets, 30mg single dose per period

pioglitazone and fostamatinib

Group Type EXPERIMENTAL

pioglitazone

Intervention Type DRUG

oral tablets, 30mg single dose per period

Interventions

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fostamatinib

oral tablets, 100mg (2 X 50mg) twice daily for 8 days

Intervention Type DRUG

pioglitazone

oral tablets, 30mg single dose per period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures
* Males or females (of non-child bearing potential) aged 18 to 55 years (inclusive)
* Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
* Males must be willing to use barrier contraception ie, condoms, from the first administration until 2 weeks after the last administration of the investigational product

Exclusion Criteria

* History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
* Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
* Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
* Any previous treatment with fostamatinib or pioglitazone

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes