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

Phase 1

Completed

• Conditions: Healthy Volunteers; Rheumatoid Arthritis
• Interventions: Drug: Digoxin; Drug: Fostamatinib

• Registration Number: NCT01355354
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-17
• Study First Submitted QC: 2011-05-17
• Study First Posted: 2011-05-18
• Study Start: 2011-06
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-05
• Last Update Posted: 2011-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Digoxin	Fostamatinib
2	Fostamatinib	Fostamatinib
1	Digoxin	Digoxin

Primary Outcome Measures

Name	Time	Method
To investigate whether the plasma concentration-time profiles and resulting PK parameters of digoxin are altered during steady-state fostamatinib administration. Digoxin AUCss and Cmaxss will be measured	Day 8 and Day 15

Secondary Outcome Measures

Name	Time	Method
To examine the safety + tolerability of fostamatinib in combination with digoxin. Assessments: Adverse events, lab assessments, vital signs, phys exam,12-lead ECG. Absolute values and change in baseline for any of these parameters will be reported	From screening, Day 1 - Day 17, through to Follow up visit
To examine the steady-state PK of R406 during co-administration of fostamatinib with digoxin at steady-state. R406 AUCss, tmaxss and Cmaxss will be measured	Day 15
To examine the urinary steady-state PK of digoxin in healthy subjects when administered alone and in combination with fostamatinib at steady-state. Digoxin Ae(0-t), Fe, and CLr will be measured	Day 8 and Day 15

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom