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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001061-27 | EudraCT Number | EudraCT |
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The primary objective of this trial is to investigate the safety and tolerability of BI 639667 in healthy male subjects following oral administration of single rising doses.
Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality as well as investigation of linearity and pharmacodynamics (PD) of BI 639667 after single dosing and the assessment of the PK/PD relationship.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 639667 | Experimental | single rising doses given as oral solution |
|
| Placebo | Placebo Comparator | placebo solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo solution |
| |
| BI 639667 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with drug-related adverse events | up to 19 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 120 hours postdose | |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 120 hours postdose |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
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| Drug |
oral solution BI 639667, single rising doses |
|