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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515222-92-00 | EU Trial (CTIS) Number | ||
| U1111-1307-8288 | Other Identifier | WHO - International Clinical Trials Registry Platform (ICTRP) |
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The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
| |
| Placebo group | Placebo Comparator | Applicable for part 1a and part 2 of the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3776528 | Drug | BI 3776528 |
| |
| Placebo matching BI 3776528 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1a and Part 2: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator | up to 62 days | |
| Part 1b: AUC0-tz of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) | up to 27 days | |
| Part 1b: Cmax of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma) | up to 27 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1a: AUC0-∞ of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 27 days | |
| Part 1a: Cmax of BI 3776528 in plasma | up to 27 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 |
|---|---|---|---|---|---|---|
| Charité Research Organisation GmbH | Recruiting | Berlin | 10117 | 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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This trial will be conducted in 2 parts: Part 1 (single doses) and Part 2 (multiple doses). Part 1 comprises of 2 subparts: Parts 1a and 1b.
Part 1b starts only after the dose has been tested in part 1a and was safe and of acceptable tolerability.
Part 2 of the study will only commence after the successful administration of the planned dose to the last subject in part 1a.
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Part 1a of this trial is a randomized, single-blind, and placebo-controlled. Part 1b of the trial is randomized, open-label, and with a two-way crossover design.
Part 2 of the trial is single-blind, randomized, and placebo-controlled.
| Drug |
Placebo matching BI 3776528 |
|
| short-acting benzodiazepine | Drug | short-acting benzodiazepine |
|
| Part 1b: AUC0-∞ of BI 3776528 in plasma | up to 27 days |
| Part 2: AUCτ,ss of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) | up to 27 days |
| Part 2: Cmin,ss of BI 3776528 in plasma (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) | up to 27 days |
| Part 2: Cmax,ss of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) | up to 27 days |