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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006856-16 | EudraCT Number |
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Single-rising dose (SRD) part The main objectives of the SRD part of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1815368 in healthy male subjects following oral administration of single rising doses.
Bioavailability (BA) part The main objective of the BA part is to investigate the relative bioavailability of a tablet formulation versus oral solution and to assess the influence of food on the relative bioavailability of the tablet formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRD part: BI 1815368 | Experimental |
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| SRD part: Placebo | Placebo Comparator |
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| BA part: T1-R-T2 | Experimental | R: BI 1815368 formulation 1, fasted condition T1: BI 1815368 formulation 2, fasted condition T2: BI 1815368 formulation 2, fed condition |
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| BA part: R-T2-T1 | Experimental |
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| BA part: T2-T1-R | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1815368 formulation 1 | Drug | BI 1815368 formulation 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| SRD part: Occurrence of any treatment-emergent adverse event | Up to Day 14 | |
| BA part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | Up to Day 5 | |
| BA part: Maximum measured concentration of BI 1815368 in plasma (Cmax) | Up to Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| SRD part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | up to Day 6 | |
| SRD part: Maximum measured concentration of BI 1815368 in plasma (Cmax) | up to Day 6 |
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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 |
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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:
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This study has 2 parts: a single rising dose (SRD) part and a bioavailability (BA) part. For the SRD part the intervention study model is sequential, while for the BA part the intervention study model is crossover.
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For the Single Rising Dose (SRD) part the participant is blinded. For the bioavailability (BA) part no masking is applicable.
| Placebo | Drug | Placebo |
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| BI 1815368 formulation 2 | Drug | BI 1815368 formulation 2 |
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| BA part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to Day 5 |