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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003080-18 | EudraCT Number |
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This study is open to adults aged 18 years and older. People without kidney problems and people who have moderate or severe kidney 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 kidney problems. Kidney problems may change how a medicine is taken up in the blood. All participants take a single tablet of BI 1015550.
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 kidney 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 Severe renal impairment | Experimental | Participants with severe renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 15-29 milliliter(mL)/minute(min)/1.73 meter(m)²), and not requiring dialysis, administered orally one film-coated tablet of 18 milligram (mg) of BI 1015550 with 240 mL of water after an overnight fast of at least 10 hours (h). |
|
| BI 1015550 Moderate renal impairment | Experimental | Participants with moderate renal impairment (eGFR 30-59 mL/min/1.73 m²) administered orally one film-coated tablet of 18 mg of BI 1015550 with 240 mL of water after an overnight fast of at least 10 h. |
|
| BI 1015550 Normal renal function | Experimental | Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) administered orally one film-coated tablet of 18 mg of BI 1015550 with 240 mL of water after an overnight fast of at least 10 h. Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment. Each participant with normal renal function could be matched to one participant with moderate renal impairment and to one participant with severe renal impairment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1015550 | Drug | BI 1015550 |
|
| 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 R-enantiomer, measured by a chiral 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups. | Within 2 hours (h) prior to drug administration 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 h after drug administration. |
| Area Under the Concentration-time Curve of 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 BI 1015550 (mixture of R-(pharmacologically active) and S-(pharmacologically inactive) enantiomers, measured by a non-chiral 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups. | Within 2 hours (h) prior to drug administration 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 h 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 R-enantiomer, measured by a chiral 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups. |
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Inclusion Criteria:
Inclusion criteria applying to all participants:
Of note, oral hormonal contraceptives are not considered as highly effective in this study due to the potential CYP3A induction by BI 1015550. Therefore, the following methods of contraception are considered adequate for female participants of childbearing potential:
Female participants are not considered to be of childbearing potential if they are either surgically sterilised (including hysterectomy) or postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases, a blood sample with levels of Follicle stimulating hormone (FSH) above 40 units per liter (U/L) and oestradiol below 30 nanograms/liter (ng/L) is confirmatory).
Further inclusion criteria apply.
Exclusion Criteria:
Exclusion criteria applying to all participants:
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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:
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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.
This Phase I trial applied a non-randomised, parallel matched-group design and included participants with moderate or severe renal impairment and participants with normal renal function (matched controls to participants with renal impairment). All trial participants received one 18 milligram BI 1015550 tablet, administered in the fasting state.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 1015550 Severe renal impairment | Participants with severe renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 15-29 milliliter(mL)/minute(min)/1.73 meter(m)²), and not requiring dialysis, administered orally one film-coated tablet of 18 milligram (mg) of BI 1015550 with 240 mL of water after an overnight fast of at least 10 hours (h). |
| FG001 | BI 1015550 Moderate renal impairment | Participants with moderate renal impairment (eGFR 30-59 mL/min/1.73 m²) administered orally one film-coated tablet of 18 mg of BI 1015550 with 240 mL of water after an overnight fast of at least 10 h. |
| FG002 | BI 1015550 Normal renal function | Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) administered orally one film-coated tablet of 18 mg of BI 1015550 with 240 mL of water after an overnight fast of at least 10 h. Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment. Each participant with normal renal function could be matched to one participant with moderate renal impairment and to one participant with severe renal impairment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS): included all participants who received trial medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 1015550 Severe Renal Impairment | Participants with severe renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 15-29 milliliter(mL)/minute(min)/1.73 meter(m)²), and not requiring dialysis, administered orally one film-coated tablet of 18 milligram (mg) of BI 1015550 with 240 mL of water after an overnight fast of at least 10 hours (h). |
| 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 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 R-enantiomer, measured by a chiral 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups. | Pharmacokinetic parameter analysis set (PKS): included all participants in the treated set (TS) who provided at least one PK endpoint that was defined as primary or secondary and that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A participant was to be included in the PKS, even if he/she contributed only 1 PK parameter value to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | hour*nanomole/Liter |
From the time of drug administration, until the end of the on-treatment period, up to 7 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 2 weeks.
Treated set included all participants who received trial medication. 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 renal function (10), because 6 controls were matched to 1 participant with moderate renal impairment and to 1 participant with severe renal 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 Severe renal impairment | Participants with severe renal impairment (eGFR according to Chronic Kidney Disease Epidemiology Collaboration 15-29 mL/min/1.73 m²), and not requiring dialysis, administered orally one film-coated tablet of 18 mg of BI 1015550 with 240 mL of water after an overnight fast of at least 10 h. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular 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 | Jan 10, 2023 | Oct 30, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2023 | Oct 30, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
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| Maximum Measured Concentration of R-BI 1015550 in Plasma (Cmax) | Maximum measured concentration of R-BI 1015550 (the pharmacologically active R-enantiomer, measured by a chiral 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups. | Within 2 hours (h) prior to drug administration 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 h after drug administration. |
| Maximum Measured Concentration of BI 1015550 in Plasma (Cmax) | Maximum measured concentration of BI 1015550 (mixture of R-(pharmacologically active) and S-(pharmacologically inactive) enantiomers, measured by a non-chiral 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups. | Within 2 hours (h) prior to drug administration 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 h after drug administration. |
| Within 2 hours (h) prior to drug administration 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 h after drug administration. |
| 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 (mixture of R-(pharmacologically active) and S-(pharmacologically inactive) enantiomers, measured by a non-chiral 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups. | Within 2 hours (h) prior to drug administration 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 h after drug administration. |
| BG001 | BI 1015550 Moderate Renal Impairment | Participants with moderate renal impairment (eGFR 30-59 mL/min/1.73 m²) administered orally one film-coated tablet of 18 mg of BI 1015550 with 240 mL of water after an overnight fast of at least 10 h. |
| BG002 | BI 1015550 Normal Renal Function | Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) administered orally one film-coated tablet of 18 mg of BI 1015550 with 240 mL of water after an overnight fast of at least 10 h. Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment. Each participant with normal renal function could be matched to one participant with moderate renal impairment and to one participant with severe renal impairment. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Within 2 hours (h) prior to drug administration 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 h after drug administration. |
|
|
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| Primary | Area Under the Concentration-time Curve of 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 BI 1015550 (mixture of R-(pharmacologically active) and S-(pharmacologically inactive) enantiomers, measured by a non-chiral 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups. | Pharmacokinetic parameter analysis set (PKS): included all participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A participant was to be included in the PKS, even if he/she contributed only 1 PK parameter value to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | hour*nanomole/Liter | Within 2 hours (h) prior to drug administration 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 h after drug administration. |
|
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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 R-enantiomer, measured by a chiral 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups. | Pharmacokinetic parameter analysis set (PKS): included all participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A participant was to be included in the PKS, even if he/she contributed only 1 PK parameter value to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | nanomole/Liter | Within 2 hours (h) prior to drug administration 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 h after drug administration. |
|
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| Primary | Maximum Measured Concentration of BI 1015550 in Plasma (Cmax) | Maximum measured concentration of BI 1015550 (mixture of R-(pharmacologically active) and S-(pharmacologically inactive) enantiomers, measured by a non-chiral 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups. | Pharmacokinetic parameter analysis set (PKS): included all participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A participant was to be included in the PKS, even if he/she contributed only 1 PK parameter value to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | nanomole/Liter | Within 2 hours (h) prior to drug administration 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 h after drug administration. |
|
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|
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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 R-enantiomer, measured by a chiral 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups. | Pharmacokinetic parameter analysis set (PKS): included all participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A participant was to be included in the PKS, even if he/she contributed only 1 PK parameter value to the statistical assessment. Only participants with available PK data are included in the analysis. | Posted | Geometric Least Squares Mean | Standard Error | hour*nanomole/Liter | Within 2 hours (h) prior to drug administration 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 h after drug administration. |
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| Secondary | 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 (mixture of R-(pharmacologically active) and S-(pharmacologically inactive) enantiomers, measured by a non-chiral 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups. | Pharmacokinetic parameter analysis set (PKS): included all participants in the TS who provided at least one PK endpoint that was defined as primary or secondary and that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A participant was to be included in the PKS, even if he/she contributed only 1 PK parameter value to the statistical assessment. Only participants with available PK data are included in the analysis. | Posted | Geometric Least Squares Mean | Standard Error | hour*nanomole/Liter | Within 2 hours (h) prior to drug administration 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 h after drug administration. |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | BI 1015550 Normal renal function matched to severe renal impairment | Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) administered orally one film-coated tablet of 18 mg of BI 1015550 with 240 mL of water after an overnight fast of at least 10 h. Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to participants with severe renal impairment. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG002 | BI 1015550 Moderate renal impairment | Participants with moderate renal impairment (eGFR 30-59 mL/min/1.73 m²) administered orally one film-coated tablet of 18 mg of BI 1015550 with 240 mL of water after an overnight fast of at least 10 h. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG003 | BI 1015550 Normal renal function matched to moderate renal impairment | Participants with normal renal function (estimated glomerular filtration rate (eGFR) ≥90 milliliter(mL)/minute(min)/1.73 meter(m)²) administered orally one film-coated tablet of 18 mg of BI 1015550 with 240 mL of water after an overnight fast of at least 10 h. Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to participants with moderate renal impairment. | 0 | 8 | 0 | 8 | 3 | 8 |
| Haematoma | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 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.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Other |
| Ratio of adjusted geometric means was 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. | Ratio of adjusted geometric means [%] | 127.43 | 2-Sided | 90 | 85.92 | 188.99 | Ratio [%] = (adjusted geometric mean of moderate renal impairment / adjusted geometric mean matching control)*100. Intra-matched pair geometric coefficient of variation (gCV) [%] = 43.5 | Other |
| Other |
| Ratio of adjusted geometric means was 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. | Ratio of adjusted geometric means [%] | 96.57 | 2-Sided | 90 | 56.80 | 164.16 | Ratio [%] = (adjusted geometric mean of moderate renal impairment / adjusted geometric mean matching control)*100. Intra-matched pair geometric coefficient of variation (gCV) [%] = 66.2 | Other |
| Other |
| Ratio of adjusted geometric means was 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. | Ratio of adjusted geometric means [%] | 90.49 | 2-Sided | 90 | 52.40 | 156.26 | Ratio [%] = (adjusted geometric mean of moderate renal impairment / adjusted geometric mean matching control)*100. Intra-matched pair geometric coefficient of variation (gCV) [%] = 68.5 | Other |
| Other |
| Ratio of adjusted geometric means was 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. | Ratio of adjusted geometric means [%] | 136.16 | 2-Sided | 90 | 88.41 | 209.69 | Ratio [%] = (adjusted geometric mean of moderate renal impairment / adjusted geometric mean matching control)*100. Intra-matched pair geometric coefficient of variation (gCV) [%] = 52.1 | Other |
| Other |
| Ratio of adjusted geometric means was 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 effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. | Ratio of adjusted geometric means [%] | 126.61 | 2-Sided | 90 | 85.30 | 187.92 | Ratio [%] = (adjusted geometric mean of moderate renal impairment / adjusted geometric mean matching control)*100. Intra-matched pair geometric coefficient of variation (gCV) [%] = 43.6 | Other |