A Study of Fostamatinib in Subjects With Impaired Hepatic (Liver) Function

Part of paid clinical trials in Orlando, Florida.

Sponsor
AstraZeneca
Study ID
NCT01222455
Phase
PHASE1
Status
Completed

Conditions

  • Amount of R406 in Blood
  • Healthy Volunteers
  • Hepatic Impairment
  • Pharmacokinetics

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

A study to evaluate the amount of fostamatinib in the blood in subjects with impaired hepatic (liver) function compared with healthy volunteers with normal liver function. The study will also evaluate safety and tolerability in subjects with hepatic impairment.

Key Dates

Start date
Oct 31, 2010
Status verified
Jul 2011
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 1
    Mild hepatic impairment
  • Experimental: 2
    Moderate hepatic impairment
  • Experimental: 3
    Severe hepatic impairment
  • Experimental: 4
    Matched healthy volunteers with normal hepatic function

Primary Outcome Measure

To determine plasma PK parameters of R406 in subjects with varying degrees of hepatic impairment as well as in healthy subjects (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2)) [ Time Frame: From pre-dose until 120 hours after the single dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteOrlandoFlorida--

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Research Site· Orlando, FL

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