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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Amount of Pioglitazone in Blood

Healthy Volunteers

Pioglitazone

Drug-drug Interaction

Pharmacokinetics

Rheumatoid Arthritis

Treatments

Drug: pioglitazone

Drug: fostamatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01309854

D4300C00014

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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