Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
AstraZeneca
Study ID
NCT01682408
Phase
PHASE1
Status
Completed

Conditions

  • Pharmacokinetics

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets

Key Dates

Start date
Sep 30, 2012
Status verified
Dec 2012
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Part A1
    1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), fed 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed
  • Active Comparator: Part A2
    1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed 150 mg ranitidine
  • Active Comparator: Part B1
    1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)
  • Active Comparator: Part B2
    1 x 150mg mannitol based 38% drug loaded tablet (batch variant B)
  • Active Comparator: Part B3
    1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)

Primary Outcome Measure

Pharmacokinetics profile of R406 in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC). [ Time Frame: Day 1 (predose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose ]

Locations (1)

FacilityCityStateZIPSite coordinators
-Overland ParkKansas--

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