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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003642-10 | EudraCT Number |
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To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses of BI 690517
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 690517 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 690517 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| The percentage of subjects with adverse reactions, analysed as investigator defined drug-related adverse events. | The percentage of subjects with adverse reactions, analysed as investigator defined drug-related adverse events (AEs). | From the first drug administration until end of the trial, up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the BI-690517 in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) | Area under the concentration-time curve of the BI-690517 in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity). | Pharmacokinetic blood samples: 1:30 hours before drug administration and 30 minutes, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 hours after drug administration. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | Germany |
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| Maximum measured concentration of the BI-690517 in plasma (Cmax) | Maximum measured concentration of the BI-690517 in plasma (Cmax). | PK blood samples: 1:30 hours before drug administration and 30 minutes, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 hours after drug administration. |