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

Sponsor
AstraZeneca
Study ID
NCT01311622
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • warfarin — DRUG
    2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart
  • fostamatinib — DRUG
    2 x 50 mg Fostamatinib tablets (100 mg) twice daily for 13 days

Study Details

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.

Key Dates

Start date
Mar 31, 2011
Status verified
Jan 2013
Primary completion
May 31, 2011
Completion
May 31, 2011

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: warfarin
  • Experimental: warfarin and fostamatinib

Primary Outcome Measure

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 ]

Related Studies