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

Completed · Phase 1

Conditions studied: Rheumatoid Arthritis, Healthy Volunteers, Pharmacokinetics, Pioglitazone, Drug-drug Interaction, Amount of Pioglitazone in Blood

In brief

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.

Key facts

Study ID

NCT01309854

Run by

AstraZeneca

People needed

15

Starts

2011-03-01

Expected to finish

2011-05-01

Last updated by the study team

2011-07-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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