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The main objectives of this trial are to investigate pharmacokinetics, safety and tolerability of BI 1015550 in Chinese healthy male and female subjects following administration of single doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1015550 9 mg | Experimental | A single film-coated tablet of 9 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours. |
|
| BI 1015550 18 mg | Experimental | A single film-coated tablet of 18 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1015550 | Drug | A single film-coated tablet BI 1015550 taken orally after an overnight fast of at least 10 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). | Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration. |
| Maximum Measured Concentration of BI 1015550 in Plasma (Cmax) | Maximum measured concentration of BI 1015550 in plasma (Cmax). | Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any Treatment-emergent Adverse Event (AE) | Number of subjects with any treatment-emergent adverse event (AE). | Up to 7 days. |
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Inclusion criteria
Chinese subjects will only be included in the trial if they meet the following criteria:
Exclusion criteria
Subjects will not be allowed to participate, if any of the following general criteria apply:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | 100032 | China |
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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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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This was a non-randomised, uncontrolled, open label, single-dose, parallel-group design trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 1015550 9 mg | A single film-coated tablet of 9 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours. |
| FG001 | BI 1015550 18 mg | A single film-coated tablet of 18 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 1015550 9 mg | A single film-coated tablet of 9 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours. |
| BG001 | BI 1015550 18 mg | A single film-coated tablet of 18 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). | Pharmacokinetic parameter analysis set (PKS): all subjects who were treated with at least one dose of trial and who provided at least one pharmacokinetic (PK) endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomol*Hour/Liter | Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration. |
|
Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BI 1015550 9 mg | A single film-coated tablet of 9 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | 001 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 16, 2023 | Oct 29, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2023 | Nov 5, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | BI 1015550 18 mg | A single film-coated tablet of 18 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours. |
|
|
| Primary | Maximum Measured Concentration of BI 1015550 in Plasma (Cmax) | Maximum measured concentration of BI 1015550 in plasma (Cmax). | Pharmacokinetic parameter analysis set (PKS): all subjects who were treated with at least one dose of trial and who provided at least one pharmacokinetic (PK) endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomol/Liter | Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration. |
|
|
|
| Secondary | Number of Subjects With Any Treatment-emergent Adverse Event (AE) | Number of subjects with any treatment-emergent adverse event (AE). | Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. | Posted | Count of Participants | Participants | Up to 7 days. |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | BI 1015550 18 mg | A single film-coated tablet of 18 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours. | 0 | 12 | 0 | 12 | 6 | 12 |
| Aspartate aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
|
| Basophil count increased | Investigations | 26.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | 26.0 | Systematic Assessment |
|
| Eosinophil count increased | Investigations | 26.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | 26.0 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | 26.0 | Systematic Assessment |
|
| Urinary occult blood positive | Investigations | 26.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | 26.0 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | 26.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.