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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002811-45 | EudraCT Number |
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This study is open to adults aged 18 years and older. People without liver problems and people who have mild or moderate liver problems can join the study.
The purpose of this study is to find out how a medicine called BI 1015550 is taken up in the blood of people with and without liver problems. Liver problems may change how a medicine is processed in the body.
Participants are in the study for about 2 weeks. During this time, they visit the study site 6 times. On the second visit, participants stay overnight at the study site for 4 nights. At the visits, doctors take blood samples to measure the levels of BI 1015550 in participants' blood. Then they compare the results between the groups of participants with and without liver problems. The doctors also check participants' health and take note of any unwanted effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1015550 mild hepatic impairment | Experimental | Participants with mild hepatic impairment, classified as Child-Pugh A (score 5 to 6 points), administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours. |
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| BI 1015550 moderate hepatic impairment | Experimental | Participants with moderate hepatic impairment, classified as Child-Pugh B (score 7 to 9 points), administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours. |
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| BI 1015550 normal hepatic function | Experimental | Participants with normal hepatic function administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours. Participants with normal hepatic function were individually matched to participants with mild and/or moderate hepatic impairment. The matching criteria were age (± 10 years), sex and weight (± 15%). One participant with normal hepatic function could match one participant in one or both groups of participants with hepatic impairment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1015550 | Drug | BI 1015550 |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of R-BI 1015550 (the pharmacologically active enantiomer, determined using the chiral bioanalytical assay) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The model was fitted separately for the two hepatic impaired groups. | Within the 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 hours after drug administration. |
| Maximum Measured Concentration of R-BI 1015550 in Plasma (Cmax) | Maximum measured concentration of R-BI 1015550 (the pharmacologically active enantiomer, determined using the chiral bioanalytical assay) in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The model was fitted separately for the two hepatic impaired groups. | Within the 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 hours after drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of R-BI 1015550 (the pharmacologically active enantiomer, determined using the chiral bioanalytical assay) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The model was fitted separately for the two hepatic impaired groups. |
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Inclusion criteria applicable to all participants
Inclusion criteria applying only to participants with impaired hepatic function
Inclusion criteria applying only to participants with normal hepatic function
Exclusion criteria applying to all participants
Exclusion criteria applying only to participants with hepatic impairment
Exclusion criteria applying only to participants with normal hepatic function
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Kiel GmbH | Kiel | 24105 | 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.mystudywindow.com/msw/datatransparency
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All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that the participants strictly met all inclusion and none of the exclusion criteria. Participants were not to be entered in the trial if any of the entry criteria were violated.
The trial was performed as a non-randomised, single-dose, open-label, parallel, individual matched design in order to investigate pharmacokinetic(s) of BI 1015550, as well as safety and tolerability of BI 1015550 in male and female participants with mild and moderate hepatic impairment compared to individually matched control participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 1015550 mild hepatic impairment | Participants with mild hepatic impairment, classified as Child-Pugh A (score 5 to 6 points), administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours. |
| FG001 | BI 1015550 moderate hepatic impairment | Participants with moderate hepatic impairment, classified as Child-Pugh B (score 7 to 9 points), administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours. |
| FG002 | BI 1015550 normal hepatic function | Participants with normal hepatic function administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours. Participants with normal hepatic function were individually matched to participants with mild and/or moderate hepatic impairment. The matching criteria were age (± 10 years), sex and weight (± 15%). One participant with normal hepatic function could match one participant in one or both groups of participants with hepatic impairment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Treated set (TS) included all participants who were treated with 1 dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 1015550 Mild Hepatic Impairment | Participants with mild hepatic impairment, classified as Child-Pugh A (score 5 to 6 points), administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours. |
| BG001 | BI 1015550 Moderate Hepatic Impairment |
| Units | Counts |
|---|---|
| Participants |
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| 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 R-BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of R-BI 1015550 (the pharmacologically active enantiomer, determined using the chiral bioanalytical assay) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The model was fitted separately for the two hepatic impaired groups. | The pharmacokinetic parameter analysis set (PKS) included all participants in the treated set who provided at least 1 primary or secondary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was to be included in the PKS even if they contributed only 1 of the main PK parameter value to the statistical assessment. Descriptive and model-based analyses of PK parameters were based on the PKS. | Posted | Geometric Least Squares Mean | Standard Error | hour*nanomole/liter (h*nmol/L) | Within the 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 hours after drug administration. |
From the administration of BI 1015550, until the end of the on-treatment period, up to 7 days. All-cause mortality was recorded from the administration of BI 1015550 until the end of trial, up to 2 weeks.
Treated set (TS) included all participants who were treated with 1 dose of trial drug.
Adverse events are reported by impairment group according to the Statistical Analysis Plan. The sum of matched controls to the renal impairment groups (16) does not match the number of total participants with normal hepatic function (12), because 4 controls were matched to 1 participant with mild hepatic impairment and to 1 participant with moderate hepatic impairment.
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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 normal hepatic function matched to mild hepatic impairment | Participants with normal hepatic function administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours. Participants with normal hepatic function were individually matched to participants with mild hepatic impairment. The matching criteria were age (± 10 years), sex and weight (± 15%). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | 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 30, 2023 | Oct 30, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 4, 2023 | Oct 30, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
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| Within the 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 hours after drug administration. |
Participants with moderate hepatic impairment, classified as Child-Pugh B (score 7 to 9 points), administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours. |
| BG002 | BI 1015550 Normal Hepatic Function | Participants with normal hepatic function administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours. Participants with normal hepatic function were individually matched to participants with mild and/or moderate hepatic impairment. The matching criteria were age (± 10 years), sex and weight (± 15%). One participant with normal hepatic function could match one participant in one or both groups of participants with hepatic impairment. |
| BG003 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Maximum Measured Concentration of R-BI 1015550 in Plasma (Cmax) | Maximum measured concentration of R-BI 1015550 (the pharmacologically active enantiomer, determined using the chiral bioanalytical assay) in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The model was fitted separately for the two hepatic impaired groups. | The pharmacokinetic parameter analysis set (PKS) included all participants in the treated set who provided at least 1 primary or secondary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was to be included in the PKS even if they contributed only 1 of the main PK parameter value to the statistical assessment. Descriptive and model-based analyses of PK parameters were based on the PKS. | Posted | Geometric Least Squares Mean | Standard Error | nanomole/liter (nmol/L) | Within the 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 hours after drug administration. |
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| Secondary | Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of R-BI 1015550 (the pharmacologically active enantiomer, determined using the chiral bioanalytical assay) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The model was fitted separately for the two hepatic impaired groups. | The pharmacokinetic parameter analysis set (PKS) included all participants in the treated set who provided at least 1 primary or secondary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a participant was to be included in the PKS even if they contributed only 1 of the main PK parameter value to the statistical assessment. Descriptive and model-based analyses of PK parameters were based on the PKS. | Posted | Geometric Least Squares Mean | Standard Error | hour*nanomole/liter (h*nmol/L) | Within the 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 hours after drug administration. |
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| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | BI 1015550 mild hepatic impairment | Participants with mild hepatic impairment, classified as Child-Pugh A (score 5 to 6 points), administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG002 | BI 1015550 normal hepatic function matched to moderate hepatic impairment | Participants with normal hepatic function administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours. Participants with normal hepatic function were individually matched to participants with moderate hepatic impairment. The matching criteria were age (± 10 years), sex and weight (± 15%). | 0 | 8 | 0 | 8 | 1 | 8 |
| EG003 | BI 1015550 moderate hepatic impairment | Participants with moderate hepatic impairment, classified as Child-Pugh B (score 7 to 9 points), administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours. | 0 | 8 | 0 | 8 | 2 | 8 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Catheter site inflammation | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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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.
| Other |
| Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale. | Ratio of adjusted geometric means [%] | 68.65 | 2-Sided | 90 | 46.48 | 101.41 | Ratio [%] = (adjusted geometric mean of moderate hepatic impairment / adjusted geometric mean of normal hepatic function matched to moderate hepatic impairment)*100. Intra-matched pair geometric coefficient of variation (gCV) [%] = 43.0 | Other |
| Other |
| Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale. | Ratio of adjusted geometric means [%] | 131.10 | 2-Sided | 90 | 89.96 | 191.05 | Ratio [%] = (adjusted geometric mean of moderate hepatic impairment / adjusted geometric mean of normal hepatic function matched to moderate hepatic impairment)*100. Intra-matched pair geometric coefficient of variation (gCV) [%] = 41.4 | Other |