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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021187-15 | EudraCT Number | EudraCT |
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The primary objective of the current study is to investigate the safety and tolerability of BI 638683 in healthy male volunteers following oral administration of single rising doses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 638683 | Experimental | 1 single dose per subject as oral solution |
|
| Placebo solution | Placebo Comparator | 1 single dose per subject as oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 638683 or placebo | Drug | oral doses given to 6 subjects per dose group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of BI 638683 will be assessed in a descriptive way. | up to 14 days post treatment | |
| Tolerability of BI 638683 will be assessed in a descriptive way. | up to 14 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To assess pharmacodynamics of BI 638683. | up to 5 days post study drug administration | |
| To assess pharmacokinetics of BI 638683. | up to 5 days post study drug administration |
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Inclusion criteria:
healthy male subjects
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1279.1.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| Placebo solution |
| Drug |
oral doses given to 2 subjects per dose group |
|