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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)
3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed
1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)
Unnamed facility
Overland Park, Kansas, United States
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).
Time frame: 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
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).
Time frame: 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.
Time frame: up to 3 - 5 days after discharge
Description of the safety profile in terms of severity of adverse events.
Time frame: up to 3 - 5 days after discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1 x 150mg mannitol based 38% drug loaded tablet(batch variant B)
150 mg ranitidine