Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Rheumatoid Arthritis

Treatments

Drug: fostamatinib

Drug: rifampicin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01336218

D4300C00015

Details and patient eligibility

About

The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin 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 aged 18 to 55 years (inclusive)
Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
Female subjects must have a negative pregnancy test at screening and admission of each treatment period, must not be lactating, and must be of non-childbearing potential

Exclusion criteria

History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
Any clinically significant illness, medical or surgical procedure, or trauma within 4 weeks before Period 1 Day 1
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