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A study to look at how radiolabelled NXL104 is taken up, broken down and removed by the body when given as an injection into the blood stream.
An Open Label Single-Dose Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite profile and Metabolite Identification of [14C]NXL104.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]NXL104 | Drug | 500mg/100mL intravenous solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass balance after a single intravenous (IV) dose of [14C]NXL104 as generated from recovery of total radioactivity excreted in urine | 168 hours | |
| Routes of [14C]NXL104 metabolism and excretion measured through total radioactivity concentrations in urine | 168 hours | |
| Whole blood and plasma partitioning of total radioactivity through measurement of total radioactivy levels in blood | 168 hours | |
| Mass balance after a single intravenous (IV) dose of [14C]NXL104 as generated from recovery of total radioactivity excreted in faeces | 168 hours | |
| Routes of [14C]NXL104 metabolism and excretion measured through total radioactivity concentrations in faeces | 168 hours |
| Measure | Description | Time Frame |
|---|---|---|
| IV pharmacokinetics (PK) of [14C]NXL104 through calculation of Cmax, Tmax, AUC0-infinity, T1/2, MRT, terminal elimination rate constant, amount of NXL104 (Ae), % excreted, will be calculated from NXL104 concentrations in urine and faeces | Explanations for abbreviations: Cmax = Maximum concentration Tmax = Time taken to reach maximum concentration AUC 0-Infinity = Area under the plasma concentration-time curve 0-Infinity T1/2 = Terminal half-life MRT = Mean Residence Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Newell, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study site | Ruddington | Nottingham | United Kingdom |
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| Label | URL |
|---|---|
| Redacted CSP | View source |
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| Predose, 0.25, 0.5, 1,1.25,1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168 hours |
| Metabolites of [14C]NXL104 in plasma, whole blood, urine and faeces calculated from plasma,urine and faces concentration levels.Identification of major metabolites in plasma,urine and faeces where possible | Whole blood:Predose, 0.25, 0.5, 1,1.25,1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168 hoursUrine and Faeces samples Predose-144 hours |
| Safety and tolerability of NXL104 as number of patients with adverse events and assessment of Electrocardiogram (ECG) and vital signs results | Electrocardiogram (ECG) recordings at Screening Pre-dose, 1 ,24 and 168 hoursContinuous ECG monitoring 0-1 hourVital signs measurements screening pre-dose, 0.5, 1, 2, 24 and 168 hours |