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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003161-38 | EudraCT Number |
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Effects of multiple rising doses of BI 1839100 on safety, tolerability, pharmacokinetics and the effect of high-fat meal on pharmacokinetics of BI 1839100 will be assessed as well as assessing potential drug-drug interactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRD part: BI 1839100 dose group 1 | Experimental | Multiple rising dose (MRD) |
|
| MRD part: BI 1839100 dose group 2 | Experimental | Multiple rising dose (MRD) |
|
| MRD part: BI 1839100 dose group 3 | Experimental | Multiple rising dose (MRD) |
|
| MRD part: BI 1839100 dose group 4 | Experimental | Multiple rising dose (MRD) |
|
| MRD part: BI 1839100 dose group 5 | Experimental | Multiple rising dose (MRD) |
|
| MRD part: Placebo matching BI 1839100 | Placebo Comparator |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1839100 | Drug | BI 1839100 |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator | Multiple-rising dose (MRD) | up to 26 days |
| DDI part: Area under the concentration-time curve of midazolam, digoxin and rosuvastatin when administered without BI 1839100 over the time interval from 0 to the last quantifiable data point (AUC0-tz) | Drug-Drug Interaction (DDI) | up to 20 days |
| DDI part: Maximum measured concentration of midazolam, digoxin and rosuvastatin when administered without BI 1839100 in plasma (Cmax) | up to 20 days | |
| DDI part: Area under the concentration-time curve of midazolam, digoxin and rosuvastatin when co-administered with BI 1839100 over the time interval from 0 to the last quantifiable data point (AUC0-tz) | up to 7 days | |
| DDI part: Maximum measured concentration of midazolam, digoxin and rosuvastatin when co-administered with BI 1839100 in plasma (Cmax) | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| MRD part: Maximum measured concentration of the analyte in plasma after single dose (Cmax) | at Day 1 | |
| MRD part: Time from dosing to maximum measured concentration of the analyte in plasma (tmax) | at Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON-Groningen-62040 | Groningen | 9728 NZ | Netherlands |
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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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The multiple-rising dose (MRD) part of this trial is designed as single blinded to subject, randomised, and placebo-controlled within parallel dose groups.
The Drug-Drug Interaction (DDI) part of this trial is designed as open-label, within-group comparison interaction trial.
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MRD: single blinded to subject DDI: open-label
| DDI part |
| Experimental |
Drug-Drug Interaction (DDI) |
|
| Placebo matching BI 1839100 | Drug | Placebo matching BI 1839100 |
|
| midazolam | Drug | midazolam |
|
| digoxin | Drug | digoxin |
|
| rosuvastatin | Drug | rosuvastatin |
|
| MRD part: Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 12 hours (AUC0-12) | at Day 1 |
| MRD part: Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 48 hours (AUC0-48) | up to 48 hours |
| MRD part: Area under the concentration-time curve of the analyte in plasma over a uniform 12 hours dosing interval (τ) [after Nth dose] (AUCτ( ,N)) | up to 17 days |
| MRD part: Maximum measured concentration of the analyte in plasma [after Nth dose] (Cmax( ,N)) | up to 17 days |
| ID | Term |
|---|---|
| D008874 | Midazolam |
| D004077 | Digoxin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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