Trial Outcomes & Findings for This Study Tests How Healthy Men Tolerate Different Doses of BI1015550. The Study Also Tests How BI 1015550 is Taken up by the Body (NCT NCT03230487)

NCT ID: NCT03230487

Last Updated: 2025-11-28

Results Overview

Number of subjects with drug-related Adverse Events (AEs).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

42 participants

Primary outcome timeframe

For SRD: From the administration of study medication until 7 days, up to day 8. For MRD: From the first administration of study medication until 7 days after the last administration of study medication, i.e. up to 21 days after first drug administration.

Results posted on

2025-11-28

Participant Flow

Safety, tolerability, and pharmacokinetics of BI 1015550 in healthy male subjects. Single rising dose (SRD) part: Partially randomized within dose groups, placebo-controlled, single-blind, parallel-group design; Multiple rising dose (MRD) part: Partially randomized within dose groups, placebo-controlled, double-blind, parallel-group design.

All subjects were screened for eligibility to participate in the trial. Subjects attended a specialist site which ensured that they (the subjects) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomized to trial treatment if any one of the specific entry criteria was violated.

Participant milestones

Participant milestones
Measure	Placebo Single Dose (SD) Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	Placebo Multiple Dose (MD) Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 36 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 48 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 6 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 12 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14
Overall Study STARTED	6	8	6	6	8	8
Overall Study COMPLETED	6	8	6	5	8	8
Overall Study NOT COMPLETED	0	0	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Single Dose (SD) Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	Placebo Multiple Dose (MD) Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 36 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 48 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 6 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 12 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14
Overall Study Adverse Event	0	0	0	1	0	0

Baseline Characteristics

This Study Tests How Healthy Men Tolerate Different Doses of BI1015550. The Study Also Tests How BI 1015550 is Taken up by the Body

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Single Dose (SD) n=6 Participants Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	Placebo Multiple Dose (MD) n=8 Participants Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 36 Milligram (mg) Single Dose (SD) n=6 Participants Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 48 Milligram (mg) Single Dose (SD) n=6 Participants Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 6 Milligram (mg) Twice Daily Multiple Dose (MD) n=8 Participants Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 12 Milligram (mg) Twice Daily Multiple Dose (MD) n=8 Participants Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	Total n=42 Participants Total of all reporting groups
Age, Continuous	34.3 Years STANDARD_DEVIATION 7.9 • n=30 Participants	33.8 Years STANDARD_DEVIATION 6.6 • n=30 Participants	32.2 Years STANDARD_DEVIATION 6.6 • n=60 Participants	38.2 Years STANDARD_DEVIATION 7.9 • n=92 Participants	35.8 Years STANDARD_DEVIATION 8.7 • n=21 Participants	33.5 Years STANDARD_DEVIATION 5.3 • n=60 Participants	34.6 Years STANDARD_DEVIATION 7.0 • n=65 Participants
Sex: Female, Male Female	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=92 Participants	0 Participants n=21 Participants	0 Participants n=60 Participants	0 Participants n=65 Participants
Sex: Female, Male Male	6 Participants n=30 Participants	8 Participants n=30 Participants	6 Participants n=60 Participants	6 Participants n=92 Participants	8 Participants n=21 Participants	8 Participants n=60 Participants	42 Participants n=65 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=92 Participants	0 Participants n=21 Participants	0 Participants n=60 Participants	0 Participants n=65 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants	1 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=92 Participants	0 Participants n=21 Participants	0 Participants n=60 Participants	1 Participants n=65 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=92 Participants	0 Participants n=21 Participants	0 Participants n=60 Participants	0 Participants n=65 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants	1 Participants n=30 Participants	1 Participants n=60 Participants	0 Participants n=92 Participants	0 Participants n=21 Participants	0 Participants n=60 Participants	2 Participants n=65 Participants
Race (NIH/OMB) White	6 Participants n=30 Participants	6 Participants n=30 Participants	5 Participants n=60 Participants	6 Participants n=92 Participants	8 Participants n=21 Participants	8 Participants n=60 Participants	39 Participants n=65 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=92 Participants	0 Participants n=21 Participants	0 Participants n=60 Participants	0 Participants n=65 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=92 Participants	0 Participants n=21 Participants	0 Participants n=60 Participants	0 Participants n=65 Participants

PRIMARY outcome

Timeframe: For SRD: From the administration of study medication until 7 days, up to day 8. For MRD: From the first administration of study medication until 7 days after the last administration of study medication, i.e. up to 21 days after first drug administration.

Population: Treated Set

Number of subjects with drug-related Adverse Events (AEs).

Outcome measures

Outcome measures
Measure	Placebo Single Dose (SD) n=6 Participants Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	Placebo Multiple Dose (MD) n=8 Participants Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 36 milligram (mg) Single Dose (SD) n=6 Participants Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 48 milligram (mg) Single Dose (SD) n=6 Participants Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 6 milligram (mg) twice daily Multiple Dose (MD) n=8 Participants Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 12 milligram (mg) twice daily Multiple Dose (MD) n=8 Participants Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14
Number of Subjects With Drug-related Adverse Events (AEs)	1 Participants	1 Participants	2 Participants	4 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00 hours after drug administration

Population: Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints.

Part 1 (SRD): Area under the concentration-time curve of the BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

Outcome measures

Outcome measures
Measure	Placebo Single Dose (SD) n=6 Participants Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	Placebo Multiple Dose (MD) n=5 Participants Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 36 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 48 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 6 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 12 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14
Part 1 (SRD): Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	5910 nanomole*hour/liter (nmol∙h/L) Geometric Coefficient of Variation 21.2	8700 nanomole*hour/liter (nmol∙h/L) Geometric Coefficient of Variation 17.2	—	—	—	—

SECONDARY outcome

Part 1 (SRD): Maximum measured concentration of the BI 1015550 in plasma (Cmax).

Outcome measures

Outcome measures
Measure	Placebo Single Dose (SD) n=6 Participants Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	Placebo Multiple Dose (MD) n=6 Participants Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 36 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 48 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 6 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 12 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14
Part 1 (SRD): Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax)	710 nanomole/liter (nmol/L) Geometric Coefficient of Variation 20.7	955 nanomole/liter (nmol/L) Geometric Coefficient of Variation 15.5	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 hours after drug administration

Part 2 (MRD) - After the first dose : Area under the concentration-time curve of the BI 1015550 in plasma over a uniform dosing interval tau after administration of the first dose (AUCτ,1).

Outcome measures

Outcome measures
Measure	Placebo Single Dose (SD) n=8 Participants Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	Placebo Multiple Dose (MD) n=8 Participants Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 36 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 48 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 6 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 12 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14
Part 2 (MRD) - After the First Dose : Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over a Uniform Dosing Interval Tau After Administration of the First Dose (AUCτ,1)	564 nanomole*hour/liter (nmol∙h/L) Geometric Coefficient of Variation 24.8	1370 nanomole*hour/liter (nmol∙h/L) Geometric Coefficient of Variation 15.9	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:55 hours after drug administration

Part 2 (MRD) - After the first dose : Maximum measured concentration of the BI 1015550 in plasma (Cmax).

Outcome measures

Outcome measures
Measure	Placebo Single Dose (SD) n=8 Participants Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	Placebo Multiple Dose (MD) n=8 Participants Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 36 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 48 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 6 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 12 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14
Part 2 (MRD) - After the First Dose : Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax)	103 nanomole/liter (nmol/L) Geometric Coefficient of Variation 28.2	229 nanomole/liter (nmol/L) Geometric Coefficient of Variation 29.9	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken within 5 minutes pre-dose and at hours 311:55, 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00

Part 2 (MRD) - After the last dose: Area under the concentration-time curve of the BI 1015550 in plasma at steady state over a uniform dosing interval tau (AUCtau,ss).

Outcome measures

Outcome measures
Measure	Placebo Single Dose (SD) n=8 Participants Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	Placebo Multiple Dose (MD) n=8 Participants Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 36 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 48 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 6 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 12 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14
Part 2 (MRD) - After the Last Dose: Area Under the Concentration-time Curve of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUCtau,ss)	1050 nanomole*hour/liter (nmol∙h/L) Geometric Coefficient of Variation 25.7	2300 nanomole*hour/liter (nmol∙h/L) Geometric Coefficient of Variation 15.8	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00, 336:00, 346:00, 360:00, 384:00, 408:00, 432:00, 456:00, 480:00, 504:00

Part 2 (MRD) - After the last dose: Maximum measured concentration of the BI 1015550 in plasma at steady state over a uniform dosing interval tau (Cmax,ss).

Outcome measures

Outcome measures
Measure	Placebo Single Dose (SD) n=8 Participants Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	Placebo Multiple Dose (MD) n=8 Participants Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 36 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 48 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 6 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 12 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14
Part 2 (MRD) - After the Last Dose: Maximum Measured Concentration of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax,ss)	164 nanomole/liter (nmol/L) Geometric Coefficient of Variation 21.3	348 nanomole/liter (nmol/L) Geometric Coefficient of Variation 14.1	—	—	—	—

SECONDARY outcome

Timeframe: Up to 504 hours following first drug administration, Please find the time frame in description section.

Part 2 (MRD) - Accumulation ratio based on Cmax,ss (RA,Cmax). First Dose PK samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:55 hours after drug administration. Last Dose PK samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00, 336:00, 346:00, 360:00, 384:00, 408:00, 432:00, 456:00, 480:00, 504:00.

Outcome measures

Outcome measures
Measure	Placebo Single Dose (SD) n=8 Participants Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	Placebo Multiple Dose (MD) n=8 Participants Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 36 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 48 milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1	BI 1015550 6 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14	BI 1015550 12 milligram (mg) twice daily Multiple Dose (MD) Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14
Part 2 (MRD) - Accumulation Ratio Based on Cmax,ss (RA,Cmax)	1.60 Ratio Geometric Coefficient of Variation 35.0	1.52 Ratio Geometric Coefficient of Variation 23.6	—	—	—	—

SECONDARY outcome

Timeframe: Up to 324 hours following first drug administration, Please find the time frame in description section.

Part 2 (MRD) - Accumulation ratio based on AUC0-tau (RA,AUC). First Dose PK samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 hours after drug administration. Last Dose PK samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00.