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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001968-22 | EudraCT Number |
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The study aims to observe how YM150 was absorbed, distributed and excreted after dosing with a radio labeled drinking solution.
Healthy male subjects are admitted on Day 0. Subjects receive a single oral dose of 14C-labeled YM150 in the morning of Day 1 and remain in the unit for 7 days (6 nights). Blood, plasma, urine and feces samples are collected until 120 hrs after dosing for analysis of 14C-labeled radioactivity, YM150, YM-222714 and other metabolites. Expired air is collected as well for assessment of 14C-radioactivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM150 | Drug | 14C-labeled YM150, oral solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of 14C-labeled YM150 assessed by whole blood, plasma, urine, feces and expired air concentrations | AUCinf (Amount excreted in urine extrapolated until infinity), AUClast (Amount excreted in urine until last sample), Cmax (Maximum concentration), tmax (Time to attain maximum concentration), tlag (Absorption lag time) and t1/2 (Apparent terminal elimination half-life). Excretion rate and cumulative excretion of radioactivity in urine, feces and expired air. | Day 1 - Day 6 |
| Pharmacokinetics of YM150 and metabolites assessed by plasma and urine concentrations | - AUCinf, AUClast, Cmax, tmax, tlag and t1/2. In urine - amount excreted in urine, CLR (Renal clearance) and % of dose excreted. | Day 1 - Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of the metabolic profile of YM150 in human plasma, urine and feces | 0 - 2 hours Day 1 | |
| Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events | Day 1 - 14 |
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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 |
|---|---|---|---|---|---|---|
| PRA International EDS NL | Zuidlaren | 9471 GP | Netherlands |
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| ID | Term |
|---|---|
| C569750 | darexaban |
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