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| Name | Class |
|---|---|
| Shionogi Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]Xeruborbactam | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]Xeruborbactam | Drug | Carbon Radiolabeled Xeruborbactam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Fe) | Day 1 to Day 15 | |
| Cumulative amount of total radioactivity excreted expressed as percentage of the radioactive dose administered (CumFe) | Day 1 to Day 15 | |
| Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on Cmax | Day 1 to Day 15 | |
| Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on AUC0-last | Day 1 to Day 15 | |
| Ratio of plasma xeruborbactam concentrations relative to total radioactivity based on AUC0-inf | Day 1 to Day 15 | |
| Whole blood to plasma total radioactivity ratio based on Cmax | Day 1 to Day 15 | |
| Whole blood to plasma total radioactivity ratio based on AUC0-last | Day 1 to Day 15 | |
| Whole blood to plasma total radioactivity ratio based on AUC0-inf | Day 1 to Day 15 | |
| Maximum plasma concentration (Cmax) for xeruborbactam | Day 1 to Day 15 | |
| Time to maximum plasma concentration (Tmax) for xeruborbactam |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with Treatment-Emergent Adverse Events | Day 1 to Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Nottingham | NG11 6JS | United Kingdom |
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| Day 1 to Day 15 |
| Area under the concentration time curve from zero to infinity (AUC0-inf) for xeruborbactam | Day 1 to Day 15 |
| Maximum plasma and whole blood concentration (Cmax) of total radioactivity | Day 1 to Day 15 |
| Time to maximum plasma and whole blood concentration (Tmax) of total radioactivity | 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 | Day 1 to Day 15 |
| Amount of total radioactivity excreted in urine (Aeu) | Day 1 to Day 15 |
| Amount of total radioactivity excreted in in urine expressed as a percentage of the radioactive dose administered (Feu) | 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) | 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 | Day 1 to Day 15 |
| Total amount of radioactivity excreted (Ae) | Day 1 to Day 15 |
| Cumulative amount of total radioactivity excreted (CumAe) | Day 1 to Day 15 |
| Ratio of whole blood to plasma total radioactivity | Day 1 to Day 15 |