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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01355354
First received: May 17, 2011
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Healthy Volunteers
Rheumatoid Arthritis
Drug: Digoxin
Drug: Fostamatinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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 [ Time Frame: Day 8 and Day 15 ] [ Designated as safety issue: No ]

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 [ Time Frame: From screening, Day 1 - Day 17, through to Follow up visit ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 21
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Digoxin
Drug: Digoxin
oral tablets, 0.25mg bd on Day 1 and 0.25 Once daily from Day 2 to 15
Experimental: 2
Fostamatinib
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355354

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01355354     History of Changes
Other Study ID Numbers: D4300C00026
Study First Received: May 17, 2011
Last Updated: October 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase 1
healthy volunteers
pharmacokinetics
Rheumatoid arthritis
RA, Fostamatinib
Digoxin, drug-drug interaction
Scientific terminology: Rheumatoid arthritis
Healthy Volunteers
Pharmacokinetics
Fostamatinib
Digoxin
drug-drug interaction
Laymen terminology: Rheumatoid arthritis
Amount of Digoxin in blood

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014