Trial Outcomes & Findings for A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Kidney Problems (NCT NCT05718648)
NCT ID: NCT05718648
Last Updated: 2025-11-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
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.
Results posted on
2025-11-28
Participant Flow
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.
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.
Participant milestones
| Measure |
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).
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
10
|
|
Overall Study
Treated
|
8
|
8
|
10
|
|
Overall Study
COMPLETED
|
8
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Kidney Problems
Baseline characteristics by cohort
| Measure |
BI 1015550 Severe Renal Impairment
n=8 Participants
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
n=8 Participants
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
n=10 Participants
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.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.4 Years
STANDARD_DEVIATION 12.3 • n=9 Participants
|
65.3 Years
STANDARD_DEVIATION 10.3 • n=6 Participants
|
60.7 Years
STANDARD_DEVIATION 11.9 • n=9 Participants
|
63.8 Years
STANDARD_DEVIATION 11.6 • n=78 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
11 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
15 Participants
n=78 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
26 Participants
n=78 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
BI 1015550 Severe renal impairment
n=8 Participants
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 Normal renal function matched to severe renal impairment
n=8 Participants
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.
|
BI 1015550 Moderate renal impairment
n=8 Participants
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 matched to moderate renal impairment
n=8 Participants
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 moderate renal impairment.
|
|---|---|---|---|---|
|
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)
|
3347.73 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.18
|
2590.32 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.18
|
3141.86 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.19
|
2285.92 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.19
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
BI 1015550 Severe renal impairment
n=8 Participants
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 Normal renal function matched to severe renal impairment
n=8 Participants
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.
|
BI 1015550 Moderate renal impairment
n=8 Participants
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 matched to moderate renal impairment
n=8 Participants
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 moderate renal impairment.
|
|---|---|---|---|---|
|
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)
|
4367.05 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.17
|
3312.70 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.17
|
3841.47 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.16
|
3014.58 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.16
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
BI 1015550 Severe renal impairment
n=8 Participants
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 Normal renal function matched to severe renal impairment
n=8 Participants
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.
|
BI 1015550 Moderate renal impairment
n=8 Participants
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 matched to moderate renal impairment
n=8 Participants
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 moderate renal impairment.
|
|---|---|---|---|---|
|
Maximum Measured Concentration of R-BI 1015550 in Plasma (Cmax)
|
399.46 nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.12
|
464.19 nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.12
|
367.36 nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.24
|
380.43 nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.24
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
BI 1015550 Severe renal impairment
n=8 Participants
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 Normal renal function matched to severe renal impairment
n=8 Participants
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.
|
BI 1015550 Moderate renal impairment
n=8 Participants
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 matched to moderate renal impairment
n=8 Participants
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 moderate renal impairment.
|
|---|---|---|---|---|
|
Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)
|
404.41 nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.13
|
486.36 nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.13
|
359.75 nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.25
|
397.56 nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.25
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
BI 1015550 Severe renal impairment
n=7 Participants
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 Normal renal function matched to severe renal impairment
n=8 Participants
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.
|
BI 1015550 Moderate renal impairment
n=8 Participants
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 matched to moderate renal impairment
n=8 Participants
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 moderate renal impairment.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
3391.98 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.20
|
2638.63 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.18
|
3177.31 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.19
|
2333.59 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.19
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
BI 1015550 Severe renal impairment
n=7 Participants
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 Normal renal function matched to severe renal impairment
n=8 Participants
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.
|
BI 1015550 Moderate renal impairment
n=8 Participants
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 matched to moderate renal impairment
n=8 Participants
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 moderate renal impairment.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
4280.84 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.19
|
3423.14 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.18
|
3941.06 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.16
|
3112.82 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.16
|
Adverse Events
BI 1015550 Severe renal impairment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 1015550 Normal renal function matched to severe renal impairment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 1015550 Moderate renal impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1015550 Normal renal function matched to moderate renal impairment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1015550 Severe renal impairment
n=8 participants at risk
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.
|
BI 1015550 Normal renal function matched to severe renal impairment
n=8 participants at risk
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.
|
BI 1015550 Moderate renal impairment
n=8 participants at risk
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 matched to moderate renal impairment
n=8 participants at risk
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.
|
|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
25.0%
2/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
|
Vascular disorders
Haematoma
|
0.00%
0/8 • 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.
|
12.5%
1/8 • 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.
|
0.00%
0/8 • 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.
|
12.5%
1/8 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
12.5%
1/8 • 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.
|
0.00%
0/8 • 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.
|
|
Infections and infestations
COVID-19
|
12.5%
1/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
12.5%
1/8 • 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.
|
0.00%
0/8 • 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.
|
|
Investigations
Lipase increased
|
0.00%
0/8 • 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.
|
12.5%
1/8 • 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.
|
12.5%
1/8 • 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.
|
12.5%
1/8 • 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.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/8 • 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.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • 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.
|
12.5%
1/8 • 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.
|
12.5%
1/8 • 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.
|
12.5%
1/8 • 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.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER