Study in healthy males to assess bioavailability of 4 different fostamatinib tablets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Oral tablets, 50 mg x 2, single dose
Oral tablets, 50 mg x 3, single dose
Oral tablets, 100 mg, single dose
Research Site
Overland Park, Kansas, United States
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)
Assessments will include but is not limited to: plasma R406 AUC, Cmax
Time frame: From Pre-dose until 96 hours post dose of each treatment period
To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 150-mg tablet versus 3 x 50-mg tablets (Phase III formulation)
Assessments will include but is not limited to: plasma R406 AUC, Cmax )
Time frame: From pre-dose until 96 hours post dose of each treatment period
To examine the safety and tolerability of fostamatinib 50 mg, 100 mg, and 150 mg tablet batches
The safety endpoints will include adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
Time frame: From pre-dose until 96 hours post dose of each treatment period
To estimate the within subject variability in R406 exposure when fostamatinib 50 mg tablets are administered on 2 separate occasions.
Assessments will include but is not limited to: plasma R406 plasma AUC0-t, t1/2, and tmax
Time frame: From pre-dose until 96 hours post dose of each treatment period
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Oral tablets, 150 mg, single dose
Oral tablets, 50 mg x 2, single dose