Study in healthy males to assess bioavailability of single fostamatinib with iv micro tracer dose.
A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib with Respect to an Intravenous Micro Tracer Dose of \[14C\] R406 in Healthy Male Volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
37
Fostamatinib 50 mg tablet
Fostamatinib 100 μg \[14C\] R406 intravenous micro tracer dose
Unnamed facility
Ruddington, Nottingham, United Kingdom
The percent of absolute bioavailability (F) of R406 after oral administration of fostamatinib.
Time frame: Up to 96 hours post dose
Total radioactivity of [14C] R406 after an intravenous infusion of [14C]R406 in terms of AUC, AUC(0-t), Cmax, t1/2λz, MRT, CL, Vz.
AUC-Area under the plasma concentration time curve; AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration; Cmax - max plasma concentration; t½ λz-Terminal half-life; MRT- Mean residence time; CL - Total body clearance; Vz - Volume of distribution during the terminal phase
Time frame: Up to 96 hours post dose
Pharmacokinetic (PK) profile of a single oral dose of fostamatinib and a radiolabelled intravenous micro tracer dose of [14C] R406.
PK Parameters: AUC, AUC (0-t), Cmax, t½ λz and MRT
Time frame: 0, 30min, 1h, 1h 30min, 1h 45min, 1h 50min, 1h 55min, 2, 2h 5min, 2h 10min, 2h 15min, 2h30min, 3, 3h 30min, 5h30min, 9h, 12h, 18h, 24h, 30h, 48h, 72h, 96h post-dose
Number of participants with Adverse Events.
Time frame: Up to Day 12
Safety profile in terms of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs and physical examination findings.
Time frame: Up to Day 12
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