Trial Outcomes & Findings for A Study in Healthy Men to Test the Influence of BI 1358894 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood (NCT NCT04099732)

Last Updated: 2025-02-27

Results Overview

Area under the concentration-time curve of the analyte (rosuvastatin) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h and 96h after drug administration. Rosuvastatin + BI 1358894 (Test 1) was measured within 3 hours before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h and 96h after drug administration.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

26 participants

Primary outcome timeframe

Rosuvastatin (R1): within 3 hours before and up to 96 hours after drug administration. Rosuvastatin + BI 1358894 (1): within 3 hours before and up to 96 hours after drug administration. Detailed timeframe is provided in the description section.

Results posted on

2025-02-27

Participant Flow

An open, single-dose, fixed sequence, two period crossover design to evaluate the relative bioavailability of rosuvastatin (part 1) and dabigatran (part 2) given alone and together with BI 1358894 in healthy male subjects.

All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subject) met all strictly implemented inclusion and None of the exclusion criteria. Subjects were not to be assigned to treatment groups if any one of the specific entry criteria were violated.

Participant milestones

Participant milestones
Measure	Part 1: Rosuvastatin (R1) / Rosuvastatin + BI 1358894 (T1) In part 1, period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a high-fat, high-calorie breakfast as reference 1 (R1), followed by a washout period of at least 7 days. In part 1, period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 2 film-coated tablets of 100 mg BI 1358894 (200 mg in total) with 240 mL of water after a high-fat, high-calorie breakfast as test 1 (T1).	Part 2: Dabigatran (R2) / Dabigatran + BI 1358894 (T2) In part 2, period 1 a single oral dose of 1 hard capsule of 150 milligram (mg) dabigatran etexilate was administered with 240 milliliter (mL) of water after a high-fat, high-calorie breakfast as reference 2 (R2), followed by a washout period of at least 7 days. In part 2, period 2, a single oral dose of 1 hard capsule of 150 mg dabigatran etexilate was coadministered with a single oral dose of 2 film-coated tablets of 100 mg BI 1358894 (200 mg in total) with 240 mL of water after a high-fat, high-calorie breakfast as test 2 (T2).
Period 1 (+ Washout Period) STARTED	14	12
Period 1 (+ Washout Period) COMPLETED	14	12
Period 1 (+ Washout Period) NOT COMPLETED	0	0
Period 2 STARTED	14	12
Period 2 COMPLETED	14	12
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study in Healthy Men to Test the Influence of BI 1358894 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Rosuvastatin (R1) / Rosuvastatin + BI 1358894 (T1) n=14 Participants In part 1, period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a high-fat, high-calorie breakfast as reference 1 (R1), followed by a washout period of at least 7 days. In part 1, period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 2 film-coated tablets of 100 mg BI 1358894 (200 mg in total) with 240 mL of water after a high-fat, high-calorie breakfast as test 1 (T1).	Part 2: Dabigatran (R2) / Dabigatran + BI 1358894 (T2) n=12 Participants In part 2, period 1 a single oral dose of 1 hard capsule of 150 milligram (mg) dabigatran etexilate was administered with 240 milliliter (mL) of water after a high-fat, high-calorie breakfast as reference 2 (R2), followed by a washout period of at least 7 days. In part 2, period 2, a single oral dose of 1 hard capsule of 150 mg dabigatran etexilate was coadministered with a single oral dose of 2 film-coated tablets of 100 mg BI 1358894 (200 mg in total) with 240 mL of water after a high-fat, high-calorie breakfast as test 2 (T2).	Total n=26 Participants Total of all reporting groups
Age, Continuous	47.1 Years STANDARD_DEVIATION 7.9 • n=5 Participants	39.7 Years STANDARD_DEVIATION 8.9 • n=7 Participants	43.7 Years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Rosuvastatin (R1): within 3 hours before and up to 96 hours after drug administration. Rosuvastatin + BI 1358894 (1): within 3 hours before and up to 96 hours after drug administration. Detailed timeframe is provided in the description section.

Population: Pharmacokinetic (PK) parameter analysis set: All subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability

Outcome measures

Outcome measures
Measure	Rosuvastatin (Part 1, Reference 1) n=14 Participants In part 1, period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 ml of water after a high-fat, high-calorie breakfast as reference 1 (R1).	Rosuvastatin + BI 1358894 (Part 1, Test 1) n=14 Participants In part 1, period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 2 film-coated tablets of 100 mg BI 1358894 (200 mg in total) with 240 mL of water after a high-fat, high-calorie breakfast as test 1 (T1).
Part1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	21.19 Hours * nanogramm / milliliter Standard Error 1.13	38.85 Hours * nanogramm / milliliter Standard Error 1.13

PRIMARY outcome

Timeframe: Rosuvastatin (R1): within 3 hours before and up to 96 hours after drug administration. Rosuvastatin + BI 1358894 (T1): within 3 hours before and up to 96 hours after drug administration. Detailed timeframe is provided in the description section.

Maximum measured concentration of the analyte (rosuvastatin) in Plasma (Cmax). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h and 96h after drug administration. Rosuvastatin + BI 1358894 (Test 1) was measured within 3 hours before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h and 96h after drug administration.

Outcome measures

Outcome measures
Measure	Rosuvastatin (Part 1, Reference 1) n=14 Participants In part 1, period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 ml of water after a high-fat, high-calorie breakfast as reference 1 (R1).	Rosuvastatin + BI 1358894 (Part 1, Test 1) n=14 Participants In part 1, period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 2 film-coated tablets of 100 mg BI 1358894 (200 mg in total) with 240 mL of water after a high-fat, high-calorie breakfast as test 1 (T1).
Part 1: Maximum Measured Concentration of the Analyte (Rosuvastatin) in Plasma (Cmax)	1.46 Nanogramm / milliliter Standard Error 1.14	2.54 Nanogramm / milliliter Standard Error 1.14

PRIMARY outcome

Timeframe: Dabigatran (2): within 3 hours before and up to 72 hours after drug administration. Dabigatran + BI 1358894 (T2): within 3 hours before and up to 72 hours after drug administration. Detailed time frame is in description section.

Population: Pharmacokinetic (PK) parameter analysis set: All subjects included in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Area under the concentration-time curve of the analyte (dabigatran) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration. Dabigatran + BI 1358894 (Test 2) was measured within 3h before drug administration and 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration.

Outcome measures

Outcome measures
Measure	Rosuvastatin (Part 1, Reference 1) n=12 Participants In part 1, period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 ml of water after a high-fat, high-calorie breakfast as reference 1 (R1).	Rosuvastatin + BI 1358894 (Part 1, Test 1) n=12 Participants In part 1, period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 2 film-coated tablets of 100 mg BI 1358894 (200 mg in total) with 240 mL of water after a high-fat, high-calorie breakfast as test 1 (T1).
Part 2: Area Under the Concentration-time Curve of the Analyte (Dabigatran) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	1121.67 Hours * nanogram / milliliter Standard Deviation 1.08	1335.96 Hours * nanogram / milliliter Standard Deviation 1.08

PRIMARY outcome

Timeframe: Dabigatran (R2): within 3 hours before and up to 72 hours after drug administration. Dabigatran + BI 1358894 (T2): within 3 hours before and up to 72 hours after drug administration. Detailed time frame is in description section.

Maximum measured concentration of the analyte (dabigatran) in plasma (Cmax). Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration. Dabigatran + BI 1358894 (Test 2) was measured within 3h before drug administration and 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration.

Outcome measures

Outcome measures
Measure	Rosuvastatin (Part 1, Reference 1) n=12 Participants In part 1, period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 ml of water after a high-fat, high-calorie breakfast as reference 1 (R1).	Rosuvastatin + BI 1358894 (Part 1, Test 1) n=12 Participants In part 1, period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 2 film-coated tablets of 100 mg BI 1358894 (200 mg in total) with 240 mL of water after a high-fat, high-calorie breakfast as test 1 (T1).
Part 2: Maximum Measured Concentration of the Analyte (Dabigatran) in Plasma (Cmax)	112.75 Nanogram / milliliter Standard Error 1.09	134.40 Nanogram / milliliter Standard Error 1.09

SECONDARY outcome

Area under the concentration-time curve of the analyte (rosuvastatin) in plasma over the time interval from 0 to the last quantifiable data Point (AUC0-tz). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h and 96h after drug administration. Rosuvastatin + BI 1358894 (Test1) was measured within 3 hours before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h and 96h after drug administration.

Outcome measures

Outcome measures
Measure	Rosuvastatin (Part 1, Reference 1) n=14 Participants In part 1, period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 ml of water after a high-fat, high-calorie breakfast as reference 1 (R1).	Rosuvastatin + BI 1358894 (Part 1, Test 1) n=14 Participants In part 1, period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 2 film-coated tablets of 100 mg BI 1358894 (200 mg in total) with 240 mL of water after a high-fat, high-calorie breakfast as test 1 (T1).
Part 1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	17.56 Hours * nanogram / milliliter Standard Error 1.14	32.74 Hours * nanogram / milliliter Standard Error 1.14

SECONDARY outcome

Population: Pharmacokinetic (PK) parameter analysis set: All patients included in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Area under the concentration-time curve of the analyte (dabigatran) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Dabigatran (Reference 2) was measured within 3h before drug administration and 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration. Dabigatran + BI 1358894 (Test 2) was measured within 3h before drug administration and 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration.

Outcome measures

Outcome measures
Measure	Rosuvastatin (Part 1, Reference 1) n=12 Participants In part 1, period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 ml of water after a high-fat, high-calorie breakfast as reference 1 (R1).	Rosuvastatin + BI 1358894 (Part 1, Test 1) n=12 Participants In part 1, period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 2 film-coated tablets of 100 mg BI 1358894 (200 mg in total) with 240 mL of water after a high-fat, high-calorie breakfast as test 1 (T1).
Part 2: Area Under the Concentration-time Curve of the Analyte (Dabigatran) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	1086.15 Hours * nanogram / milliliter Standard Error 1.08	1304.61 Hours * nanogram / milliliter Standard Error 1.08

Adverse Events

Rosuvastatin (Part 1, Reference 1)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Rosuvastatin + BI 1358894 (Part 1, Test 1)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Dabigatran (Part 2, Reference 2)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Dabigatran + BI 1355894 (Part 2, Test 2)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rosuvastatin (Part 1, Reference 1) n=14 participants at risk In part 1, period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 ml of water after a high-fat, high-calorie breakfast as reference 1 (R1).	Rosuvastatin + BI 1358894 (Part 1, Test 1) n=14 participants at risk In part 1, period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 2 film-coated tablets of 100 mg BI 1358894 (200 mg in total) with 240 mL of water after a high-fat, high-calorie breakfast as test 1 (T1).	Dabigatran (Part 2, Reference 2) n=12 participants at risk In part 2, period 1 a single oral dose of 1 hard capsule of 150 milligram (mg) dabigatran etexilate was administered with 240 ml of water after a high-fat, high-calorie breakfast as reference 2 (R2).	Dabigatran + BI 1355894 (Part 2, Test 2) n=12 participants at risk In part 2, period 2, a single oral dose of 1 hard capsule of 150 mg dabigatran etexilate was coadministered with a single oral dose of 2 film-coated tablets of 100 mg BI 1358894 (200 mg in total) with 240 mL of water after a high-fat, high-calorie breakfast as test 2 (T2).
Infections and infestations Gastrointestinal infection	7.1% 1/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.
Infections and infestations Nasopharyngitis	0.00% 0/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	8.3% 1/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.
Infections and infestations Rhinitis	0.00% 0/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	7.1% 1/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.
Injury, poisoning and procedural complications Meniscus injury	7.1% 1/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	8.3% 1/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.
Nervous system disorders Dizziness	0.00% 0/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	14.3% 2/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	8.3% 1/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.
Nervous system disorders Headache	7.1% 1/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	64.3% 9/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	16.7% 2/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	33.3% 4/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.
Renal and urinary disorders Nocturia	0.00% 0/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	7.1% 1/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	8.3% 1/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.
Renal and urinary disorders Pollakiuria	0.00% 0/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	7.1% 1/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/14 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	0.00% 0/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.	8.3% 1/12 • Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2. Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.

Additional Information

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