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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Rheumatoid Arthritis

Treatments

Drug: warfarin

Drug: fostamatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01311622

D4300C00013

Details and patient eligibility

About

The purpose of this study is to determine whether fostamatinib influences the plasma concentration of warfarin and changes its blood thinning effect, and to investigate how safe and tolerable it is when administered with warfarin.

Enrollment

15 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 (including genotyping screening sample for CYP2C9 and VKORC1).
Males or females (of non-childbearing potential) aged 18 to 55 years (inclusive)
Subjects must be negative for occult blood (stool card) prior to administration.
Body weight of at least 50 kg and body mass index (BMI) between 18 and 35 kg/m2 inclusive

Exclusion criteria

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, or influence the results of the study.
Healthy subject predicted to be most sensitive to warfarin based on CYP2C9 and VKORC1 genotypes.
A protein C and/or protein S deficiency.
Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
Previous treatment with warfarin for a clinical indication (ie, participation in a previous warfarin interaction study is acceptable).