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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004622-15 | EudraCT Number |
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The purpose of this study is to investigate how quickly and to what extent ACT-246475 is absorbed, distributed, metabolized (broken down) and eliminated from the body. ACT-246475 will be labeled with 14-Carbon (14C) and, in this way can be traced in blood, urine, and feces. This study will also investigate how safe is ACT-246475 and how well it is tolerated when administered to healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment and observation period | Experimental | On Day 1, the subjects will receive a single s.c. dose of 16 mg 14C-radiolabeled ACT-246475 in the fasted state. Subjects will be followed by an observation period of 3 days (72 h) during which blood, urine, and feces samples will be collected. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-246475 | Drug | Single s.c. dose of 16 mg ACT-246475 including 3.7 MBq (100 μCi) 14C-radiolabeled ACT 246475 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative excretion of total 14C-radioactivity in urine and feces | Cumulative amount of total 14C-radioactivity excreted in urine and feces will be calculated by summing up the amount of total 14C-radioactivity of the samples excreted in each collection interval | Up to 54 days |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Viatris Innovation GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Herzzentrum Bad Krozingen | Bad Krozingen | 79189 | Germany | |||
| Universitäts-Herzzentrum Freiburg |
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| ID | Term |
|---|---|
| C000601315 | selatogrel |
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| Freiburg im Breisgau |
| 79106 |
| Germany |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH | Ludwigshafen | 67063 | Germany |