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

Sponsor
AstraZeneca
Study ID
NCT01355354
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jun 30, 2011
Status verified
Oct 2011
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
21 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 1
    Digoxin
  • Experimental: 2
    Fostamatinib

Primary Outcome Measure

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 ]

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