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Trial record 25 of 595 for:    WARFARIN

Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin 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.
 
ClinicalTrials.gov Identifier: NCT01311622
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE February 21, 2011
First Posted Date  ICMJE March 9, 2011
Last Update Posted Date January 31, 2013
Study Start Date  ICMJE March 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01311622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2011)
  • 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 ]
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin in Healthy Subjects
Official Title  ICMJE An Open-Label, Single Centre Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin When Co-Administered With Fostamatinib in Healthy Subjects
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Rheumatoid Arthritis
  • Healthy Subjects
Intervention  ICMJE
  • Drug: warfarin
    2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart
    Other Name: Marevan
  • Drug: fostamatinib
    2 x 50 mg Fostamatinib tablets (100 mg) twice daily for 13 days
Study Arms  ICMJE
  • Experimental: warfarin
    Intervention: Drug: warfarin
  • Experimental: warfarin and fostamatinib
    Interventions:
    • Drug: warfarin
    • Drug: fostamatinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2011)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01311622
Other Study ID Numbers  ICMJE D4300C00013
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Ritter, BM BCh MRCP FRCP Quintiles, Phase 1 Unit, London
Study Director: Mark Layton, MD MRCP (UK) AstraZeneca
PRS Account AstraZeneca
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP