Study in healthy males to assess the bioavailability of 4 different fostamatinib tablets
Study identifier:D4300C00018
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An open-label, partially randomized, 5-way crossover study in healthy volunteers to assess the relative bioavailability of 100 and 150 mg fostamatinib tablets compared with 50 mg fostamatinib tablets
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Fostamatinib
Sex
Male
Actual Enrollment
24
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Aug 2011
Primary Completion Date: 01 Oct 2011
Study Completion Date: 01 Oct 2011
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Jan 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: A Fostamatinib 50 mg tablet x 2 (Phase 3 batch) | Drug: Fostamatinib Oral tablets, 50 mg x 2, single dose |
| Sham Comparator: B Fostamatinib 50 mg tablet x 3 (Phase 3 batch) | Drug: Fostamatinib Oral tablets, 50 mg x 3, single dose |
| Experimental: C Fostamatinib 100 mg tablet (new formulation) | Drug: Fostamatinib Oral tablets, 100 mg, single dose |
| Experimental: D Fostamatinib 150 mg tablet (new formulation) | Drug: Fostamatinib Oral tablets, 150 mg, single dose |
| Experimental: E Fostamatinib 50 mg tablet x 2 (Phase 3 batch) | Drug: Fostamatinib Oral tablets, 50 mg x 2, single dose |
