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

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
AstraZeneca
Study ID
NCT01387308
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Aug 31, 2011
Status verified
Oct 2011
Primary completion
Oct 31, 2011
Completion
Oct 31, 2011

Study Design

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

Arms

  • Experimental: A
    Fostamatinib 50 mg tablet x 2 (Phase 3 batch)
  • Sham Comparator: B
    Fostamatinib 50 mg tablet x 3 (Phase 3 batch)
  • Experimental: C
    Fostamatinib 100 mg tablet (new formulation)
  • Experimental: D
    Fostamatinib 150 mg tablet (new formulation)
  • Experimental: E
    Fostamatinib 50 mg tablet x 2 (Phase 3 batch)

Primary Outcome Measure

To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 100-mg tablet versus 2 x 50-mg tablets (Phase III formulation) [ Time Frame: From Pre-dose 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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