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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509293-29-00 | Registry Identifier | CTIS | |
| U1111-1299-6907 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following multiple rising doses of BI 3000202 and to investigate the effect of BI 3000202 on the metabolism of midazolam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose group 1 | Experimental | Group receiving placebo or dose 1 of BI 3000202 |
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| Dose group 2 | Experimental | Group receiving placebo or dose 2 of BI 3000202 |
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| Dose group 3 | Experimental | Group receiving midazolam, midazolam and dose 3 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo |
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| Dose group 4 | Experimental | Group receiving midazolam, midazolam and dose 4 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3000202 | Drug | BI 3000202 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with drug-related adverse events | Up to day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 12 hours (AUC0-12) | Up to 12 hours | |
| Maximum measured concentration BI 3000202 in plasma (Cmax) | Up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Life Science Services - Clinical Research | Edegem | 2650 | Belgium |
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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.mystudywindow.com/msw/datatransparency
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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The multiple rising dose part of the trial will be conducted in a parallel group assignment. The effect of midazolam interaction will be assessed sequentially.
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The multiple rising dose part of the trial will be blinded to the participants and investigators . The effect of midazolam will be assessed open label.
| Placebo | Drug | Placebo-matching BI 3000202 |
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| Midazolam | Drug | Midazolam |
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| Area under the concentration-time curve of BI 3000202 in plasma over a uniform dosing interval τ (AUCτ,ss) at steady state | Up to day 20 |
| Maximum measured concentration of BI 3000202 in plasma (Cmax,ss) at steady state | Up to day 20 |
| Time from dosing to the maximum measured concentration of BI 3000202 in plasma (tmax,ss) at steady state | Up to day 20 |
| Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) after a single dose | Up to 2 days |
| Maximum measured concentration of midazolam in plasma (Cmax) after a single dose | Up to 2 days |
| D006571 | Heterocyclic Compounds |