Trial Outcomes & Findings for A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Liver Problems (NCT NCT05661344)

Last Updated: 2025-11-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

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.

Results posted on

2025-11-28

Participant Flow

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.

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

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	8	8	12
Overall Study Treated	8	8	12
Overall Study COMPLETED	8	8	12
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 Liver Problems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 1015550 Mild Hepatic Impairment n=8 Participants 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.	BI 1015550 Moderate Hepatic Impairment n=8 Participants 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.	BI 1015550 Normal Hepatic Function n=12 Participants 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.	Total n=28 Participants Total of all reporting groups
Age, Continuous	65.9 Years STANDARD_DEVIATION 5.5 • n=9 Participants	61.0 Years STANDARD_DEVIATION 7.4 • n=6 Participants	64.7 Years STANDARD_DEVIATION 9.04 • n=9 Participants	64.0 Years STANDARD_DEVIATION 7.7 • n=78 Participants
Sex: Female, Male Female	4 Participants n=9 Participants	4 Participants n=6 Participants	6 Participants n=9 Participants	14 Participants n=78 Participants
Sex: Female, Male Male	4 Participants n=9 Participants	4 Participants n=6 Participants	6 Participants n=9 Participants	14 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	12 Participants n=9 Participants	28 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 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.

Population: 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.

Outcome measures

Outcome measures
Measure	BI 1015550 mild hepatic impairment n=8 Participants 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.	BI 1015550 moderate hepatic impairment n=8 Participants 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.	BI 1015550 normal hepatic function matched to mild hepatic impairment n=8 Participants 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%).	BI 1015550 normal hepatic function matched to moderate hepatic impairment n=8 Participants 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%).
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)	2913.55 hournanomole/liter (hnmol/L) Standard Error NA Adjusted geometric standard error = 1.09	2837.74 hournanomole/liter (hnmol/L) Standard Error NA Adjusted geometric standard error = 1.16	2786.43 hournanomole/liter (hnmol/L) Standard Error NA Adjusted geometric standard error = 1.09	2168.11 hournanomole/liter (hnmol/L) Standard Error NA Adjusted geometric standard error = 1.16

PRIMARY outcome

Timeframe: 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 (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.

Outcome measures

Outcome measures
Measure	BI 1015550 mild hepatic impairment n=8 Participants 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.	BI 1015550 moderate hepatic impairment n=8 Participants 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.	BI 1015550 normal hepatic function matched to mild hepatic impairment n=8 Participants 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%).	BI 1015550 normal hepatic function matched to moderate hepatic impairment n=8 Participants 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%).
Maximum Measured Concentration of R-BI 1015550 in Plasma (Cmax)	409.35 nanomole/liter (nmol/L) Standard Error NA Adjusted geometric standard error = 1.15	277.67 nanomole/liter (nmol/L) Standard Error NA Adjusted geometric standard error = 1.19	491.48 nanomole/liter (nmol/L) Standard Error NA Adjusted geometric standard error = 1.15	404.46 nanomole/liter (nmol/L) Standard Error NA Adjusted geometric standard error = 1.19

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	BI 1015550 mild hepatic impairment n=8 Participants 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.	BI 1015550 moderate hepatic impairment n=8 Participants 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.	BI 1015550 normal hepatic function matched to mild hepatic impairment n=8 Participants 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%).	BI 1015550 normal hepatic function matched to moderate hepatic impairment n=8 Participants 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%).
Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	2964.46 hournanomole/liter (hnmol/L) Standard Error NA Adjusted geometric standard error = 1.09	2866.58 hournanomole/liter (hnmol/L) Standard Error NA Adjusted geometric standard error = 1.16	2811.48 hournanomole/liter (hnmol/L) Standard Error NA Adjusted geometric standard error = 1.09	2186.53 hournanomole/liter (hnmol/L) Standard Error NA Adjusted geometric standard error = 1.16

Adverse Events

BI 1015550 normal hepatic function matched to mild hepatic impairment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

BI 1015550 mild hepatic impairment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

BI 1015550 normal hepatic function matched to moderate hepatic impairment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

BI 1015550 moderate hepatic impairment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BI 1015550 normal hepatic function matched to mild hepatic impairment n=8 participants at risk 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%).	BI 1015550 mild hepatic impairment n=8 participants at risk 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.	BI 1015550 normal hepatic function matched to moderate hepatic impairment n=8 participants at risk 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%).	BI 1015550 moderate hepatic impairment n=8 participants at risk 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.
Nervous system disorders Headache	25.0% 2/8 • 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.	0.00% 0/8 • 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.	12.5% 1/8 • 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.	12.5% 1/8 • 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.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/8 • 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.	0.00% 0/8 • 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.	0.00% 0/8 • 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.	12.5% 1/8 • 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.
General disorders Catheter site inflammation	0.00% 0/8 • 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.	12.5% 1/8 • 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.	0.00% 0/8 • 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.	0.00% 0/8 • 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.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/8 • 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.	12.5% 1/8 • 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.	0.00% 0/8 • 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.	0.00% 0/8 • 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.
Investigations Lipase increased	0.00% 0/8 • 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.	0.00% 0/8 • 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.	0.00% 0/8 • 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.	12.5% 1/8 • 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.

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.
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