Assess Pharmacokinetics of Fostamatinib in fed and fasted state in combination with Ranitidine to assess bioavailability - PK Combination
Study identifier:D4300C00019
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open-label, Single-center, 2-Part, Randomized 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
Medical condition
pharmacokinetics
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed, Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A), Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B), Ranitidine
Sex
All
Actual Enrollment
28
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Sept 2012
Primary Completion Date: 01 Dec 2012
Study Completion Date: 01 Dec 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Jan 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| 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 | Drug: Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) Drug: Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) 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 | Drug: Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) Drug: Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed Drug: Ranitidine 150 mg ranitidine |
| Active Comparator: Part B1 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A) | Drug: Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A) 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) | Drug: Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B) 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) | Drug: Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) |
Contacts
Investigators
Principal Investigator
Eleanor Lisbon
Quintiles Phase I unit
6700 w 115th st Overland Park, Ks 66211
