The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made by the body, the chemical composition of these metabolites and their profile over time in blood and urine will be determined.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Quotient Clinical Ltd
Ruddington, Nottingham, United Kingdom
Mass balance of BCX4161 after a single oral dose of [14C] BCX4161 based upon radioactivity excreted in urine, expired air and feces
Time frame: Determined from samples drawn up to 14 days post-dose
Chemical structure elucidation of major metabolites of [14C] BCX4161 in urine, plasma, feces, urine
Time frame: Determined from samples drawn up to 4 days post-dose
Plasma pharmacokinetics (Cmax, Tmax, Tlag, AUC(0-last), AUC(0-inf), CL/F, Vz/F, AUC%extrapolated,t1/2, as applicable for each analyte) of total radioactivity, BCX4161, [14C] BCX4161 and major metabolites of [14C] BCX4161
Time frame: Data generated from samples drawn up to 7 days post-dose
Urinary pharmacokinetics (CLr, Ae, and % dose excreted) of BCX4161
Time frame: Data generated from samples drawn up to 7 days post-dose
Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations
Time frame: Over the duration of the study, approximately 6 weeks from screening through follow-up
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