This is a single-dose, phase 1 open-label study to determine the mass balance recovery and metabolic profiling and identification for intravenous (IV) administered \[14C\]xeruborbactam. This study will investigate the primary route of excretion, profile \[14C\]xeruborbactam metabolites in plasma, urine and faeces, and assess the safety, tolerability, and pharmacokinetics (PK) of a single IV dose of \[14C\]xeruborbactam in healthy adult male participants.
Age range
30 Years – 65 Years
Sex
MALE
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Amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Fe)
Timeframe: Day 1 to Day 15
Cumulative amount of total radioactivity excreted expressed as percentage of the radioactive dose administered (CumFe)
Timeframe: Day 1 to Day 15
Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on Cmax
Timeframe: Day 1 to Day 15
Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on AUC0-last
Timeframe: Day 1 to Day 15
Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on AUC0-inf
Timeframe: Day 1 to Day 15
Whole blood to plasma total radioactivity ratio based on Cmax
Timeframe: Day 1 to Day 15
Whole blood to plasma total radioactivity ratio based on AUC0-last
Timeframe: Day 1 to Day 15
Whole blood to plasma total radioactivity ratio based on AUC0-inf
Timeframe: Day 1 to Day 15
Maximum plasma concentration (Cmax) for xeruborbactam
Timeframe: Day 1 to Day 15
Time to maximum plasma concentration (Tmax) for xeruborbactam
Timeframe: Day 1 to Day 15
Area under the concentration time curve from zero to infinity (AUC0-inf) for xeruborbactam
Timeframe: Day 1 to Day 15
Maximum plasma and whole blood concentration (Cmax) of total radioactivity
Timeframe: Day 1 to Day 15
Time to maximum plasma and whole blood concentration (Tmax) of total radioactivity
Timeframe: Day 1 to Day 15
Area under the concentration time curve from zero to infinity (AUC0-inf) of total radioactivity in plasma and whole blood
Timeframe: Day 1 to Day 15
Amount of total radioactivity excreted in urine (Aeu)
Timeframe: Day 1 to Day 15
Amount of total radioactivity excreted in in urine expressed as a percentage of the radioactive dose administered (Feu)
Timeframe: Day 1 to Day 15
Identification of the chemical structure of each metabolite accounting for 5% or more in plasma by area under the time concentration curve (AUC)
Timeframe: Day 1 to Day 15
Identification of the chemical structure of each metabolite in urine and faeces that account for 5% or more of the administered radioactive dose
Timeframe: Day 1 to Day 15
Total amount of radioactivity excreted (Ae)
Timeframe: Day 1 to Day 15
Cumulative amount of total radioactivity excreted (CumAe)
Timeframe: Day 1 to Day 15
Ratio of whole blood to plasma total radioactivity
Timeframe: Day 1 to Day 15