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Completed

NCT Number: NCT01311622

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

The purpose of this study is to determine whether fostamatinib influences the plasma concentration of warfarin and changes its blood thinning effect, and to investigate how safe and tolerable it is when administered with warfarin.

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Key information

Conditions

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

Age range

18 year–55 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 (including genotyping screening sample for CYP2C9 and VKORC1).
  • Males or females (of non-childbearing potential) aged 18 to 55 years (inclusive)
  • Subjects must be negative for occult blood (stool card) prior to administration.
  • Body weight of at least 50 kg and body mass index (BMI) between 18 and 35 kg/m2 inclusive

Exclusion criteria

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, or influence the results of the study.
  • Healthy subject predicted to be most sensitive to warfarin based on CYP2C9 and VKORC1 genotypes.
  • A protein C and/or protein S deficiency.
  • Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
  • Previous treatment with warfarin for a clinical indication (ie, participation in a previous warfarin interaction study is acceptable).

Treatment and study plan

Warfarin

Drug

2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart

Other names: Marevan

Fostamatinib

Drug

2 x 50 mg Fostamatinib tablets (100 mg) twice daily for 13 days

Primary outcomes

  1. To determine PK parameters of R- and S-warfarin including but not limited to AUC and Cmax

    Time frame: From pre-dose to 168 h post dose relative to each single warfarin dose

    • Pharmacokinetics of warfarin measured by AUC
    • Pharmacokinetics of warfarin measured Cmax

Secondary outcomes

  1. To measure International Normalised Ratio (INR) following administration of warfarin

    Time frame: From pre-dose to 168 h post dose relative to each single warfarin dose

  2. To assess the steady-state pharmacokinetics of R406 (active metabolite of fostamatinib) by measuring AUCss, Cmax,ss, tmax,ss and CL/F

    Time frame: From predose on Day 11 until 12 h post dose on Day 14 relative to fostamatinib dosing

    • Steady state Pharmacokinetics of R406 measured by AUCss
    • Steady state Pharmacokinetics of R406 measured by Cmax
    • Steady state Pharmacokinetics of R406 measured by ss
    • Steady state Pharmacokinetics of R406 measured by tmax
    • Steady state Pharmacokinetics of R406 measured by CL/F

  3. Safety and tolerability will be measured with regard to adverse events, laboratory assessments, vital signs, physical examination, and 12-lead ECG will be recorded.

    Time frame: From screening, Day -1 to Day 21 and follow up visit (Day 28)

    To examine the safety and tolerability of fostamatinib in combination with Warfarin: Adverse events, laboratory assessments, vital signs, physical examination, and 12-lead ECG

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open-Label, Single Centre Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin When Co-Administered With Fostamatinib in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 9, 2011
Registry last updated
Jan 31, 2013

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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