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Fostamatinib- 1 x mannitol-based 38% drug-loaded

Phase 1

Pharmacokinetics | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 28, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Fostamatinib- 1 x mannitol-based 38% drug-loaded · 1 trial · 1 indication

Phase 1 1
NCT01682408Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess BioavailabilityPharmacokinetics
COMPLETED28 Analytics
PHASE1COMPLETED
Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability
Pharmacokinetics
NCT0168240828
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Study Endpoints

Primary Endpoints

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).
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

Secondary Endpoints

Pharmacokinetic profile of R406 in terms of area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)], time to Cmax (tmax), terminal half-life (t1/2λz), terminal rate constant (λz).
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
Description of the safety profile in terms of frequency of adverse events.
up to 3 - 5 days after discharge
Description of the safety profile in terms of severity of adverse events.
up to 3 - 5 days after discharge
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part A1ACTIVE_COMPARATOR1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), fed 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed
Part A2ACTIVE_COMPARATOR1 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
Part B1ACTIVE_COMPARATOR1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)
Part B2ACTIVE_COMPARATOR1 x 150mg mannitol based 38% drug loaded tablet (batch variant B)
Part B3ACTIVE_COMPARATOR1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)

Interventions

NameTypeDescription
Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)DRUG1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)
Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fedDRUG3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed
Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)DRUG1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)
Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B)DRUG1 x 150mg mannitol based 38% drug loaded tablet(batch variant B)
RanitidineDRUG150 mg ranitidine
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study-specific procedures including the genetic sampling and analyses * Volunteers will be males or females aged 18 to 55 years (inclusive) and with a weight of at least 50 kg and body mass index (BMI) betwee...

Countries:United States
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