Back to resultsEffects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects
Primary Purpose
Healthy Volunteers, Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Digoxin
Fostamatinib
Sponsored by
About this trial
This is an interventional basic science trial for Healthy Volunteers focused on measuring Phase 1, healthy volunteers, pharmacokinetics, Rheumatoid arthritis, RA, Fostamatinib, Digoxin, drug-drug interaction, Scientific terminology: Rheumatoid arthritis, Fostamatinib, Digoxin, drug-drug interaction, Laymen terminology: Rheumatoid arthritis, Amount of Digoxin in blood
Eligibility Criteria
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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Digoxin
Fostamatinib
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01355354
Brief Title
Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Rheumatoid Arthritis
Keywords
Phase 1, healthy volunteers, pharmacokinetics, Rheumatoid arthritis, RA, Fostamatinib, Digoxin, drug-drug interaction, Scientific terminology: Rheumatoid arthritis, Fostamatinib, Digoxin, drug-drug interaction, Laymen terminology: Rheumatoid arthritis, Amount of Digoxin in blood
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Digoxin
Arm Title
2
Arm Type
Experimental
Arm Description
Fostamatinib
Intervention Type
Drug
Intervention Name(s)
Digoxin
Intervention Description
oral tablets, 0.25mg bd on Day 1 and 0.25 Once daily from Day 2 to 15
Intervention Type
Drug
Intervention Name(s)
Fostamatinib
Intervention Description
oral tablets, 100mg (2 X 50mg) bd from Day 9 - 15
Primary Outcome Measure Information:
Title
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
Time Frame
Day 8 and Day 15
Secondary Outcome Measure Information:
Title
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
Time Frame
From screening, Day 1 - Day 17, through to Follow up visit
Title
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
Time Frame
Day 15
Title
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
Time Frame
Day 8 and Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Research Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26514315
Citation
Martin P, Gillen M, Millson D, Oliver S, Brealey C, Elsby R, Baluom M, Lau D, Mant T. Effects of Fostamatinib on the Pharmacokinetics of Digoxin (a P-Glycoprotein Substrate): Results From in Vitro and Phase I Clinical Studies. Clin Ther. 2015 Dec 1;37(12):2811-22. doi: 10.1016/j.clinthera.2015.09.018. Epub 2015 Oct 26.
Results Reference
derived
Learn more about this trial
Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects
We'll reach out to this number within 24 hrs