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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003483-70 | EudraCT Number | EudraCT |
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Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1021958 | Experimental | Single rising dose (SRD) part |
|
| BI 1021958 (Food effect) | Experimental | Food effect part (FE) |
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| Placebo to BI 1021958 | Placebo Comparator | Matching placebo as drinking solution and tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1021958 | Drug | tablet |
| |
| BI 1021958 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with clinically relevant findings in physical examination | up to 14 days postdose | |
| Number of participants with clinically relevant findings in vital signs | up to 14 days postdose | |
| Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results | up to 14 days postdose | |
| Number of participants with significant changes from baseline laboratory measurements | up to 14 days postdose | |
| Number of participants with adverse events | up to 14 days postdose | |
| Assessment of tolerability by investigator | up to 14 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of BI 1021958 in plasma) | up to 72h postdose | |
| area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) | up to 72h postdose |
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Inclusion criteria:
1. Healthy male subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1310.1.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| Drug |
drinking solution / tablet |
|
| Placebo to BI 1021958 | Drug | SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast |
|
| AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point) | up to 72h postdose |