The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
15
oral tablets, 150mg (3 X 50mg) single dose per period
oral tablets, 600mg (2 X 300mg) 8 doses over 8 days
Research Site
Overland Park, Kansas, United States
To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured
Time frame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose
To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC (0-t), terminal half life, and tmax will be measured
Time frame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose
To examine the safety and tolerability of fostamatinib in combination with rifampicin.
Assessments include: Adverse events, laboratory assessments, vital signs, physical examination and 12-lead electrocardiogram. Absolute values and change in baseline for any of these parameters will be reported.
Time frame: From screening, Day 1 - Day 25, up to follow up visit
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