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The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3821001 in healthy male trial participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose group 1 | Experimental | part A |
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| Dose group 2 | Experimental | part A |
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| Dose group 3 | Experimental | part A |
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| Dose group 4 | Experimental | part A |
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| Dose group 5 | Experimental | part A |
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| Dose group 6 | Experimental | part A |
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| Dose group 7 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3821001 | Drug | BI 3821001 |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator | Up to 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in blood over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to 60 days | |
| Maximum measured concentration of the analyte in blood (Cmax) | Up to 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Contact | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Berlin GmbH | Recruiting | Berlin | 13627 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases(in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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part B
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| Dose group 8 | Experimental | part B |
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| Dose group 9 | Experimental | part B |
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| Placebo group | Placebo Comparator |
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| Placebo | Drug | Placebo |
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| Percentage of participants treated with investigational drug who experience a treatment-emergent adverse event | Up to 60 days |