Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
AstraZeneca
Study ID
NCT01336218
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • fostamatinib — DRUG
    oral tablets, 150mg (3 X 50mg) single dose per period
  • rifampicin — DRUG
    oral tablets, 600mg (2 X 300mg) 8 doses over 8 days

Study Details

The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects

Key Dates

Start date
Apr 30, 2011
Status verified
Jul 2011
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

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

Arms

  • Experimental: 1
    Fostamatinib
  • Experimental: 2
    Rifampicin

Primary Outcome Measure

To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured [ Time Frame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteOverland ParkKansas--

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