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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001701-27 | EudraCT Number |
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Subjects receive a single oral dose of radioactive ASP1707 on Day 1. Blood, plasma, urine and feces samples are collected for analysis of 14C-radioactivity and ASP1707. Metabolites are collected until at least 144 hours after dosing.
Subjects are admitted to the clinic on Day -1 and receive a single oral dose of 14C-labeled ASP1707 on Day 1. They remain in the clinic for 6 days and are discharged on Day 7 if sufficient recovery of administered radioactivity is achieved, or the total excretion (urine + feces) per 24 hours is less than 1% of the administered dose during 2 consecutive 24-hour intervals. If these conditions are not met, the residential period may be prolonged for a maximum of 3 days. If after this time one of the conditions is still not met, subjects are requested to continue collecting their urine and/or feces at home for another 2 days. If after these additional 2 days one of the conditions is still not met, the condition of recovery of radioactivity is disregarded. Therefore only the total excretion condition is to be met by collecting 24-hour intervals for urine and feces once a week for up to 2 weeks. If the excretion condition is still not met after this time, no further samples are collected and the subject is discharged from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: ASP1707 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-labeled ASP1707 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radioactivity in whole blood measured by Area under the plasma concentration - to time = infinity (AUCinf) | Day -1 until at least Day 7 | |
| Radioactivity in whole blood measured by Area under the plasma concentration - time curve to the last quantifiable concentration (AUClast) | Day -1 until at least Day 7 | |
| Radioactivity in whole blood measured by Maximum concentration (Cmax) | Day -1 until at least Day 7 | |
| Radioactivity in whole blood measured by Time to Attain Cmax (tmax) | Day -1 until at least Day 7 | |
| Radioactivity in whole blood measured by Apparent Terminal Elimination Half-life (t1/2) | Day -1 until at least Day 7 | |
| Radioactivity in whole blood measured by Apparent total body clearance (CL/F) | Day -1 until at least Day 7 | |
| Radioactivity in whole blood measured by Apparent volume of distribution (Vz/F) | Day -1 until at least Day 7 | |
| Radioactivity in plasma measured by AUCinf | Day -1 until at least Day 7 | |
| Radioactivity in plasma measured by AUClast | Day -1 until at least Day 7 | |
| Radioactivity in plasma measured by Cmax |
| Measure | Description | Time Frame |
|---|---|---|
| Profiling of metabolites in plasma, urine and feces | This will be done separately from this study and will be reported in a separate report | Day -1 until at least Day 7 |
| Safety assessed by vital signs, 12-lead ECG, laboratory tests, adverse events, physical examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Manager | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance CRU Ltd. | Leeds | LS2 9LH | United Kingdom |
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| Day -1 until at least Day 7 |
| Radioactivity in plasma measured by tmax | Day -1 until at least Day 7 |
| Radioactivity in plasma measured by t1/2 | Day -1 until at least Day 7 |
| Radioactivity in plasma measured by CL/F | Day -1 until at least Day 7 |
| Radioactivity in plasma measured by Vz/F | Day -1 until at least Day 7 |
| Radioactivity ratio of blood / plasma concentrations per time point and of Area under the plasma concentration (AUC) | Day -1 until at least Day 7 |
| Excretion rate and cumulative excretion of radioactivity in urine | Day -1 until at least Day 7 |
| Excretion rate and cumulative excretion of radioactivity in feces | Day -1 until at least Day 7 |
| Total cumulative excretion of radioactivity in urine and feces | Day -1 until at least Day 7 |
| ASP1707 in plasma measured by AUCinf | Day -1 until at least Day 7 |
| ASP1707 in plasma measured by AUClast | Day -1 until at least Day 7 |
| ASP1707 in plasma measured by Cmax | Day -1 until at least Day 7 |
| ASP1707 in plasma measured by tmax | Day -1 until at least Day 7 |
| ASP1707 in plasma measured by t1/2 | Day -1 until at least Day 7 |
| ASP1707 in plasma measured by CL/F | Day -1 until at least Day 7 |
| ASP1707 in plasma measured by Vz/F | Day -1 until at least Day 7 |
| ASP1707 in urine measured by Amount excreted unchanged extrapolated to time = infinity (Aeinf) | Day -1 until at least Day 7 |
| ASP1707 in urine measured by Amount excreted unchanged to last quantifiable sample (Aelast) | Day -1 until at least Day 7 |
| ASP1707 in urine measured by Renal Clearance (CLR) | Day -1 until at least Day 7 |
| ASP1707 in urine measured by Percentage of the dose excreted unchanged extrapolated to time = infinity (Aeinf%) | Day -1 until at least Day 7 |
| ASP1707 in urine measured by Percentage of the dose excreted unchanged to last quantifiable sample (Aelast %) | Day -1 until at least Day 7 |
| Screening to ESV (up to Day 40) |