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

Healthy Volunteers Clinical Trial

Official title:

An Open-Label, Non-Randomised, 2-Period, Single Centre Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355354
• Other study ID #: D4300C00026
• Status: Completed
• Phase: Phase 1
• First received: May 17, 2011
• Last updated: October 5, 2011
• Start date: June 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Healthy Volunteers
• Rheumatoid Arthritis

Intervention

Drug:
• Digoxin
oral tablets, 0.25mg bd on Day 1 and 0.25 Once daily from Day 2 to 15
• Fostamatinib
oral tablets, 100mg (2 X 50mg) bd from Day 9 - 15

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No