Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
AstraZeneca
Study ID
NCT01208155
Phase
PHASE1
Status
Completed

Conditions

  • Bioavailability
  • Pharmacokinetics

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Fostamatinib — DRUG
    Oral tablets, 50 mg x 2, single dose
  • Fostamatinib — DRUG
    Oral tablets, 100 mg Batch 1, single dose
  • Fostamatinib — DRUG
    Oral tablets, 100 mg Batch 2, single dose
  • Fostamatinib — DRUG
    Oral tablets, 100 mg Batch 3, single dose

Study Details

Study in healthy males to assess bioavailability of 4 different fostamatinib tablets

Key Dates

Start date
Sep 30, 2010
Status verified
Dec 2010
Primary completion
Nov 30, 2010
Completion
Nov 30, 2010

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 1
    Fostamatinib 50 mg tablet x 2
  • Experimental: 2
    Fostamatinib 100 mg tablet (batch 1)
  • Experimental: 3
    Fostamatinib 100 mg tablet (batch 2)
  • Experimental: 4
    Fostamatinib 100 mg tablet (batch 4)

Primary Outcome Measure

Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax ) [ Time Frame: Daily during Treatment Period 1 until 96 hours post dose of each treatment period ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteOverland ParkKansas--

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Research Site· Overland Park, KS

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