A Study of Fostamatinib in Subjects With Impaired Kidney Function

Part of paid clinical trials in Orlando, Florida.

Sponsor
AstraZeneca
Study ID
NCT01245790
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

A 2 stage study to evaluate the amount of fostamatinib in the blood and urine in subjects with impaired kidney (renal) function compared with healthy volunteers with normal renal function. Stage 1 will include healthy subjects and subjects with end stage renal disease, while Stage, 2 may include subjects with mild, moderate and/or severe renal impairment dependent on the outcome of Stage 1. The study will also evaluate safety and tolerability in subjects with renal impairment.

Key Dates

Start date
Nov 30, 2010
Status verified
Jun 2011
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 1
    Healthy subjects (Stage 1)
  • Experimental: 2
    Mild renal impairment (Stage 2)
  • Experimental: 3
    Moderate renal impairment (Stage 2)
  • Experimental: 4
    Severe renal impairment (Stage 2)
  • Experimental: 5
    End stage renal disease (Stage 1)

Primary Outcome Measure

Plasma pharmacokinetic (PK) parameters

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteOrlandoFlorida--

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