Trial Outcomes & Findings for A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood (NCT NCT04445090)

Last Updated: 2026-05-22

Results Overview

Number of participants with drug-related adverse events (AEs) is presented for SRD part. Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported. Percentages are calculated using total number of subjects per treatment as the denominator.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

68 participants

Primary outcome timeframe

From drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. Up to 14.5 days.

Results posted on

2026-05-22

Participant Flow

This study had two parts, Single rising dose (SRD) part: single-blind, partially randomized, placebo-controlled, parallel design to investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following SRD orally of BI 1569912. Bioavailability/food effect (BA/FE) part: open-label, randomized, single-dose, intra-individual, six-sequence, three-way crossover design, to investigate the relative BA of BI1569912 powder for oral solution and tablet, and the influence of food.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	SRD Part: Placebo This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.25mg BI 1569912 Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.75mg BI 1569912 Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 2.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 5.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 10.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 20.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 30.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	BA/FE Part: BI 1569912 5.0 mg Oral Solution Fasted/5.0 mg Tablet Fasted/5.0 mg Tablet Fed Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorized employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.	BA/FE Part: BI 1569912 5.0 mg Oral Solution Fasted/5.0 mg Tablet Fed/5.0 mg Tablet Fasted Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.	BA/FE Part: BI 1569912 5.0 mg Tablet Fasted/5.0 mg Oral Solution Fasted/5.0 mg Tablet Fed Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.	BA/FE Part: BI 1569912 5.0 mg Tablet Fasted/5.0 mg Tablet Fed/5.0 mg Oral Solution Fasted Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.	BA/FE Part: BI 1569912 5.0 mg Tablet Fed/5.0 mg Oral Solution Fasted/5.0 mg Tablet Fasted Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.	BA/FE Part: BI 1569912 5.0 mg Tablet Fed/5.0 mg Tablet Fasted/5.0 mg Oral Solution Fasted Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.
Overall Study STARTED	14	6	6	6	6	6	6	5	2	3	2	2	2	2
Overall Study COMPLETED	13	6	6	6	6	6	6	5	2	0	2	2	0	2
Overall Study NOT COMPLETED	1	0	0	0	0	0	0	0	0	3	0	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	SRD Part: Placebo This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	BA/FE Part: BI 1569912 5.0 mg Oral Solution Fasted/5.0 mg Tablet Fed/5.0 mg Tablet Fasted Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.	BA/FE Part: BI 1569912 5.0 mg Tablet Fed/5.0 mg Oral Solution Fasted/5.0 mg Tablet Fasted Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.
Overall Study Hold of the study	0	2	2
Overall Study Withdrawal by Subject	0	1	0
Overall Study Urgent familiar reasons	1	0	0

Baseline Characteristics

A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SRD Part: Placebo n=14 Participants This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.25mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.75mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 2.0 mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 5.0 mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 10.0 mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 20.0 mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 30.0 mg BI 1569912 n=5 Participants Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	BA/FE Part: BI 1569912 5.0 mg Oral Solution Fasted/5.0 mg Tablet Fasted/5.0 mg Tablet Fed n=2 Participants Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorized employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.	BA/FE Part: BI 1569912 5.0 mg Oral Solution Fasted/5.0 mg Tablet Fed/5.0 mg Tablet Fasted n=3 Participants Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.	BA/FE Part: BI 1569912 5.0 mg Tablet Fasted/5.0 mg Oral Solution Fasted/5.0 mg Tablet Fed n=2 Participants Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.	BA/FE Part: BI 1569912 5.0 mg Tablet Fasted/5.0 mg Tablet Fed/5.0 mg Oral Solution Fasted n=2 Participants Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.	BA/FE Part: BI 1569912 5.0 mg Tablet Fed/5.0 mg Oral Solution Fasted/5.0 mg Tablet Fasted n=2 Participants Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.	BA/FE Part: BI 1569912 5.0 mg Tablet Fed/5.0 mg Tablet Fasted/5.0 mg Oral Solution Fasted n=2 Participants Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.	Total n=68 Participants Total of all reporting groups
Age, Continuous	31.4 Years STANDARD_DEVIATION 7.2 • n=2 Participants	33.8 Years STANDARD_DEVIATION 10.1 • n=4 Participants	32.7 Years STANDARD_DEVIATION 9.2 • n=6 Participants	29.2 Years STANDARD_DEVIATION 5.9 • n=8 Participants	33.7 Years STANDARD_DEVIATION 7.0 • n=8 Participants	38.2 Years STANDARD_DEVIATION 6.9 • n=28 Participants	34.3 Years STANDARD_DEVIATION 6.7	29.2 Years STANDARD_DEVIATION 4.8 • n=71 Participants	34.5 Years STANDARD_DEVIATION 13.4 • n=40 Participants	32.7 Years STANDARD_DEVIATION 9.2 • n=120 Participants	31.0 Years STANDARD_DEVIATION 14.1 • n=40 Participants	31.5 Years STANDARD_DEVIATION 6.4 • n=39 Participants	24.5 Years STANDARD_DEVIATION 7.8 • n=40 Participants	39.0 Years STANDARD_DEVIATION 1.4 • n=40 Participants	32.6 Years STANDARD_DEVIATION 7.6 • n=40 Participants
Sex: Female, Male Female	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=28 Participants	0 Participants	0 Participants n=71 Participants	0 Participants n=40 Participants	0 Participants n=120 Participants	0 Participants n=40 Participants	0 Participants n=39 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants
Sex: Female, Male Male	14 Participants n=2 Participants	6 Participants n=4 Participants	6 Participants n=6 Participants	6 Participants n=8 Participants	6 Participants n=8 Participants	6 Participants n=28 Participants	6 Participants	5 Participants n=71 Participants	2 Participants n=40 Participants	3 Participants n=120 Participants	2 Participants n=40 Participants	2 Participants n=39 Participants	2 Participants n=40 Participants	2 Participants n=40 Participants	68 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=28 Participants	1 Participants	0 Participants n=71 Participants	0 Participants n=40 Participants	0 Participants n=120 Participants	0 Participants n=40 Participants	0 Participants n=39 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants	1 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=2 Participants	6 Participants n=4 Participants	6 Participants n=6 Participants	6 Participants n=8 Participants	6 Participants n=8 Participants	6 Participants n=28 Participants	5 Participants	5 Participants n=71 Participants	2 Participants n=40 Participants	3 Participants n=120 Participants	2 Participants n=40 Participants	2 Participants n=39 Participants	2 Participants n=40 Participants	2 Participants n=40 Participants	67 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=28 Participants	0 Participants	0 Participants n=71 Participants	0 Participants n=40 Participants	0 Participants n=120 Participants	0 Participants n=40 Participants	0 Participants n=39 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=28 Participants	1 Participants	0 Participants n=71 Participants	0 Participants n=40 Participants	0 Participants n=120 Participants	0 Participants n=40 Participants	0 Participants n=39 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Asian	3 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=28 Participants	0 Participants	0 Participants n=71 Participants	0 Participants n=40 Participants	0 Participants n=120 Participants	0 Participants n=40 Participants	0 Participants n=39 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants	3 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=28 Participants	0 Participants	0 Participants n=71 Participants	0 Participants n=40 Participants	0 Participants n=120 Participants	0 Participants n=40 Participants	0 Participants n=39 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=28 Participants	0 Participants	0 Participants n=71 Participants	0 Participants n=40 Participants	0 Participants n=120 Participants	0 Participants n=40 Participants	0 Participants n=39 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants
Race (NIH/OMB) White	11 Participants n=2 Participants	6 Participants n=4 Participants	6 Participants n=6 Participants	6 Participants n=8 Participants	6 Participants n=8 Participants	6 Participants n=28 Participants	5 Participants	5 Participants n=71 Participants	2 Participants n=40 Participants	3 Participants n=120 Participants	2 Participants n=40 Participants	2 Participants n=39 Participants	2 Participants n=40 Participants	2 Participants n=40 Participants	64 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=28 Participants	0 Participants	0 Participants n=71 Participants	0 Participants n=40 Participants	0 Participants n=120 Participants	0 Participants n=40 Participants	0 Participants n=39 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=28 Participants	0 Participants	0 Participants n=71 Participants	0 Participants n=40 Participants	0 Participants n=120 Participants	0 Participants n=40 Participants	0 Participants n=39 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=40 Participants

PRIMARY outcome

Timeframe: From drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. Up to 14.5 days.

Population: Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.

Outcome measures

Outcome measures
Measure	SRD Part: 2.0 mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: Placebo n=14 Participants This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.25mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.75mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 5.0 mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 10.0 mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 20.0 mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 30.0 mg BI 1569912 n=5 Participants Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
Part SRD: Number of Subjects With Drug-related Adverse Events (AEs)	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.

Population: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one primary or secondary pharmacokinetic endpoint that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics or due to pharmacokinetic non-evaluability. Only subjects with non-missing values were included.

Area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.

Outcome measures

Outcome measures
Measure	SRD Part: 2.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: Placebo n=5 Participants This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.25mg BI 1569912 n=10 Participants Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.75mg BI 1569912 n=11 Participants Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 5.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 10.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 20.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 30.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
BA/FE-Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	—	588.8 hours * nanomole/Liter Standard Error NA Standard error is actually adjusted geometric standard error. Adjusted geometric standard error = 1.076	567.5 hours * nanomole/Liter Standard Error NA Standard error is actually adjusted geometric standard error. Adjusted geometric standard error = 1.074	575.2 hours * nanomole/Liter Standard Error NA Standard error is actually adjusted geometric standard error. Adjusted geometric standard error = 1.074	—	—	—	—

PRIMARY outcome

Timeframe: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.

Maximum measured concentration of BI 1569912 in plasma (Cmax) is presented.

Outcome measures

Outcome measures
Measure	SRD Part: 2.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: Placebo n=8 Participants This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.25mg BI 1569912 n=12 Participants Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.75mg BI 1569912 n=11 Participants Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 5.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 10.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 20.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 30.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
BA/FE-Part: Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)	—	201.5 nanomole/Liter Standard Error NA Standard error is actually adjusted geometric standard error. Adjusted geometric standard error = 1.141	188.0 nanomole/Liter Standard Error NA Standard error is actually adjusted geometric standard error. Adjusted geometric standard error = 1.115	134.5 nanomole/Liter Standard Error NA Standard error is actually adjusted geometric standard error. Adjusted geometric standard error = 1.116	—	—	—	—

SECONDARY outcome

Timeframe: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.

Area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to infinity (AUC0-∞) is presented.

Outcome measures

Outcome measures
Measure	SRD Part: 2.0 mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: Placebo n=6 Participants This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.25mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.75mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 5.0 mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 10.0 mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 20.0 mg BI 1569912 n=5 Participants Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 30.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
SRD Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)	539 hours * nanomole/Liter Geometric Coefficient of Variation 17.4	32.9 hours * nanomole/Liter Geometric Coefficient of Variation 18.6	85.1 hours * nanomole/Liter Geometric Coefficient of Variation 18.9	252 hours * nanomole/Liter Geometric Coefficient of Variation 27.8	1110 hours * nanomole/Liter Geometric Coefficient of Variation 13.8	2540 hours * nanomole/Liter Geometric Coefficient of Variation 17.1	2900 hours * nanomole/Liter Geometric Coefficient of Variation 16.9	—

SECONDARY outcome

Timeframe: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.

Maximum measured concentration of BI 1569912 in plasma (Cmax) is presented.

Outcome measures

Outcome measures
Measure	SRD Part: 2.0 mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: Placebo n=6 Participants This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.25mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.75mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 5.0 mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 10.0 mg BI 1569912 n=6 Participants Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 20.0 mg BI 1569912 n=5 Participants Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 30.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
SRD-Part: Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)	228 nanomole/Liter Geometric Coefficient of Variation 26.9	11.9 nanomole/Liter Geometric Coefficient of Variation 26.4	33.1 nanomole/Liter Geometric Coefficient of Variation 36.7	105 nanomole/Liter Geometric Coefficient of Variation 41.6	361 nanomole/Liter Geometric Coefficient of Variation 30.9	1090 nanomole/Liter Geometric Coefficient of Variation 32.1	1100 nanomole/Liter Geometric Coefficient of Variation 27.1	—

SECONDARY outcome

Timeframe: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.

Area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to infinity (AUC0-∞) is presented.

Outcome measures

Outcome measures
Measure	SRD Part: 2.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: Placebo n=5 Participants This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.25mg BI 1569912 n=10 Participants Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.75mg BI 1569912 n=11 Participants Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 5.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 10.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 20.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 30.0 mg BI 1569912 Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
BA/FE-Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)	—	591.0 hours * nanomole/Liter Standard Error NA Standard error is actually adjusted geometric standard error. Adjusted geometric standard error = 1.076	569.8 hours * nanomole/Liter Standard Error NA Standard error is actually adjusted geometric standard error. Adjusted geometric standard error = 1.073	577.5 hours * nanomole/Liter Standard Error NA Standard error is actually adjusted geometric standard error. Adjusted geometric standard error = 1.073	—	—	—	—

Deaths: 0 deaths

BA/FE Part: BI 1569912 5.0 mg Oral Solution Fasted

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SRD Part: Placebo n=14 participants at risk This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.25mg BI 1569912 n=6 participants at risk Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 0.75mg BI 1569912 n=6 participants at risk Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 2.0 mg BI 1569912 n=6 participants at risk Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 5.0 mg BI 1569912 n=6 participants at risk Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 10.0 mg BI 1569912 n=6 participants at risk Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 20.0 mg BI 1569912 n=6 participants at risk Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	SRD Part: 30.0 mg BI 1569912 n=5 participants at risk Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.	BA/FE Part: BI 1569912 5.0 mg Tablet Fasted n=8 participants at risk Participants were administered a single oral dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorized employee of the trial site witnessed the administration of trial medication.	BA/FE Part: BI 1569912 5.0 mg Tablet Fed n=11 participants at risk Participants were administered a single oral dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorized employee of the trial site witnessed the administration of trial medication.	BA/FE Part: BI 1569912 5.0 mg Oral Solution Fasted n=12 participants at risk Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication.
General disorders Medical device site irritation	0.00% 0/14 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	20.0% 1/5 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/8 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/11 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/12 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
General disorders Pain	0.00% 0/14 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	20.0% 1/5 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/8 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/11 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/12 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
Gastrointestinal disorders Faeces soft	0.00% 0/14 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	20.0% 1/5 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/8 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/11 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/12 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/14 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	20.0% 1/5 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/8 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/11 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/12 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/14 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	16.7% 1/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/5 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/8 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/11 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/12 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/14 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	16.7% 1/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/5 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/8 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/11 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/12 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
Nervous system disorders Headache	7.1% 1/14 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	20.0% 1/5 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/8 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/11 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/12 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
Psychiatric disorders Euphoric mood	0.00% 0/14 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	20.0% 1/5 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/8 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/11 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/12 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
Psychiatric disorders Abnormal dreams	0.00% 0/14 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	16.7% 1/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/5 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/8 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/11 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/12 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
Psychiatric disorders Illusion	0.00% 0/14 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	16.7% 1/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/5 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/8 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/11 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/12 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
Skin and subcutaneous tissue disorders Papule	0.00% 0/14 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/6 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	20.0% 1/5 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/8 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/11 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.	0.00% 0/12 • SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days. Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.

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