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The purpose of this study was to determine the absorption, metabolism, and excretion of radioactivity and to characterize and determine, where possible, the metabolites present in plasma, urine, and faeces in healthy male subjects following a single oral administration of [14C]-NS-580.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of [14C] NS-580 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] NS-580 | Drug | Oral suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve, from time 0 infinity (AUC0-inf) of NS-580 in plasma | AUC0-inf of NS-580 in plasma | Pre-dose up to 28 days post-dose |
| AUC0-inf of [14C] NS-580 in plasma and whole blood for Total Radioactivity | AUC0-inf of [14C] NS-580 in plasma and whole blood | Pre-dose up to 56 days post-dose |
| Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast) | AUC0-tlast of NS-580 in plasma | Pre-dose up to 28 days post-dose |
| AUC0-tlast of [14C] NS-580 in plasma and whole blood for Total Radioactivity | AUC0-tlast of [14C] NS-580 in plasma and whole blood | Pre-dose up to 56 days post-dose |
| Maximum observed concentration (Cmax) of NS-580 | Cmax of NS-580 in plasma | Pre-dose up to 28 days post-dose |
| Cmax of [14C] NS-580 in plasma and whole blood for Total Radioactivity | Cmax of [14C] NS-580 in plasma and whole blood | Pre-dose up to 56 days post-dose |
| Time of the maximum observed concentration (Tmax) of NS-580 | Tmax of NS-580 in plasma | Pre-dose up to 28 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of NS-580 major metabolites | Pre-dose up to 56 days post-dose | |
| Incidence and severity of AEs | Pre-dose up to 56 days post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Ltd | Leeds | LS11 9EH | United Kingdom |
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| Tmax of [14C] NS-580 in plasma and whole blood for Total Radioactivity |
Tmax of [14C] NS-580 in plasma and whole blood |
| Pre-dose up to 56 days post-dose |
| Apparent terminal elimination half-life (t1/2) of NS-580 | t1/2 of NS-580 in plasma | Pre-dose up to 28 days post-dose |
| t1/2 of [14C] NS-580 in plasma and whole blood for Total Radioactivity | t1/2 of [14C] NS-580 in plasma and whole blood | Pre-dose up to 56 days post-dose |
| Renal clearance (CLR) of NS-580 | CLR of NS-580 in plasma | Pre-dose up to 28 days post-dose |
| Amount of dose administered urine recovered (Aeu) of NS-580 | Aeu of NS-580 | Pre-dose up to 56 days post-dose |
| Percentage of dose administered urine recovered (feu) of NS-580 | feu of NS-580 | Pre-dose up to 56 days post-dose |
| Total radioactivity recovery | Total radioactivity recovery in urine and faeces | Pre-dose up to 56 days post-dose |