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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01355354
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : October 6, 2011
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Rheumatoid Arthritis Drug: Digoxin Drug: Fostamatinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : June 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin

Arm Intervention/treatment
Experimental: 1
Drug: Digoxin
oral tablets, 0.25mg bd on Day 1 and 0.25 Once daily from Day 2 to 15

Experimental: 2
Drug: Digoxin
oral tablets, 0.25mg bd on Day 1 and 0.25 Once daily from Day 2 to 15

Drug: Fostamatinib
oral tablets, 100mg (2 X 50mg) bd from Day 9 - 15

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01355354

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United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AstraZeneca Identifier: NCT01355354    
Other Study ID Numbers: D4300C00026
First Posted: May 18, 2011    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011
Keywords provided by AstraZeneca:
Phase 1
healthy volunteers
Rheumatoid arthritis
RA, Fostamatinib
Digoxin, drug-drug interaction
Scientific terminology: Rheumatoid arthritis
drug-drug interaction
Laymen terminology: Rheumatoid arthritis
Amount of Digoxin in blood
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs