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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000295-29 | EudraCT Number |
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The primary objective of this trial is to investigate the safety and tolerability of BI 456906 in healthy subjects following single rising doses.
The secondary objective is the exploration of the pharmacokinetics including dose proportionality, and pharmacodynamics (PD) of BI 456906 after single dosing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 456906 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 456906 | Drug | single dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| [N (%)] of subjects with drug-related adverse events. | Up to 672 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h) | up to 168 hours | |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 672 hours |
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Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36527386 | Derived | Jungnik A, Arrubla Martinez J, Plum-Morschel L, Kapitza C, Lamers D, Thamer C, Scholch C, Desch M, Hennige AM. Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon-like peptide-1 receptor agonist BI 456906. Diabetes Obes Metab. 2023 Apr;25(4):1011-1023. doi: 10.1111/dom.14948. Epub 2023 Jan 30. |
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| ID | Term |
|---|---|
| C000726451 | BI 456906 |
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| Drug |
single dose |
|