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Completed

NCT Number: NCT01355354

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

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.

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Key information

Conditions

Healthy Volunteers Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digoxin

Drug

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

Fostamatinib

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 18, 2011
Registry last updated
Oct 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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