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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Rheumatoid Arthritis

Treatments

Drug: Fostamatinib

Drug: Digoxin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01355354

D4300C00026

Details and patient eligibility

About

The purpose of this study is to investigate the drug interaction between fostamatinib and digoxin by comparing the safety, tolerability and plasma concentration of digoxin when administered alone and with fostamatinib in healthy subjects.

Enrollment

21 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Provision of informed consent prior to any study specific procedures
Male or female subjects aged 18 to 45 years (inclusive)
Minimum weight of 50 kg and body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
Female subjects must have a negative pregnancy test at screening and on Day -1,must not be lactating, and must be of non-childbearing potential

Exclusion criteria

History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs (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 <2500/mm3 or 2.5 x 109/L
Previous treatment with fostamatinib or digoxin in the present study