Trial Outcomes & Findings for A Study in Healthy Japanese Men to Test How Different Doses of BI 1323495 Are Tolerated and How Itraconazole Influences the Amount of BI 1323495 in the Blood (NCT NCT04619251)

Results Overview

Number of participants with drug-related adverse events (AEs) is reported for Single rising dose (SRD) and Multiple dose (MD) parts is reported.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

74 participants

Primary outcome timeframe

Up to 7 days (for SRD part), up to 17 days (for MD part).

Results posted on

2024-03-27

Participant Flow

This was a two part clinical trial, the first part was single rising dose (SRD) and multiple dose (MD), the second part evaluates drug-drug interaction (DDI) with itraconazole. The study was performed in healthy Japanese men genotyped as poor metabolizers (PM) or as extensive metabolizers (EM) to test how different doses of BI 1323495 are tolerated and how itraconazole influences the amount of BI 1323495 in the blood.

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. Administrations of BI 1323495 was separated by a wash-out phase of at least 11 days.

Participant milestones

Participant milestones
Measure	SRD Part: PM Subjects, BI1323495 10mg Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 30mg Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 100mg Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 30mg Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 70mg Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 150mg Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	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 placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 30mg BID Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 60mg QD Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: Placebo This arm comprises all placebo treated participants in trial part MD, 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 from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.	DDI Part: PM Subjects, BI1323495 / BI1323495+ Itraconazole * Period 1: Participants were administered the reference treatment (R) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 together with about 240 milliliter (mL) of water on Day 1 of Period 1. One authorized employee of the trial site was witness of the administration of the trial medication. * Period 2: Participants were administered the test treatment (T) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 with about 240 milliliter (mL) of water on Day 1 of Period 2, together with multiple oral doses of 200 mg itraconazole from Day -3 to Day 7, in total 10 doses, as oral solution formulation. One authorized employee of the trial site was witness of the administration of the trial medication. Administration of BI 1323495 in treatment R and T were separated by at least 11 days.
Period 1 STARTED	6	6	6	3	3	3	9	9	9	6	14
Period 1 COMPLETED	6	6	6	3	3	3	9	9	9	6	14
Period 1 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Period 2 STARTED	0	0	0	0	0	0	0	0	0	0	14
Period 2 COMPLETED	0	0	0	0	0	0	0	0	0	0	14
Period 2 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study in Healthy Japanese Men to Test How Different Doses of BI 1323495 Are Tolerated and How Itraconazole Influences the Amount of BI 1323495 in the Blood

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SRD Part: PM Subjects, BI1323495 10mg n=6 Participants Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 30mg n=6 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 100mg n=6 Participants Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 30mg n=3 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 70mg n=3 Participants Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 150mg n=3 Participants Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: Placebo n=9 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 placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 30mg BID n=9 Participants Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 60mg QD n=9 Participants Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: Placebo n=6 Participants This arm comprises all placebo treated participants in trial part MD, 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 from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.	DDI Part: PM Subjects, BI1323495 / BI1323495+ Itraconazole n=14 Participants * Period 1: Participants were administered the reference treatment (R) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 together with about 240 milliliter (mL) of water on Day 1 of Period 1. One authorized employee of the trial site was witness of the administration of the trial medication. * Period 2: Participants were administered the test treatment (T) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 with about 240 milliliter (mL) of water on Day 1 of Period 2, together with multiple oral doses of 200 mg itraconazole from Day -3 to Day 7, in total 10 doses, as oral solution formulation. One authorized employee of the trial site was witness of the administration of the trial medication. Administration of BI 1323495 in treatment R and T were separated by at least 11 days.	Total n=74 Participants Total of all reporting groups
Age, Continuous	24.3 Years STANDARD_DEVIATION 3.8 • n=93 Participants	32.5 Years STANDARD_DEVIATION 10.3 • n=4 Participants	33.5 Years STANDARD_DEVIATION 7.6 • n=27 Participants	24.7 Years STANDARD_DEVIATION 3.1 • n=483 Participants	33.0 Years STANDARD_DEVIATION 4.6 • n=36 Participants	29.3 Years STANDARD_DEVIATION 5.5 • n=10 Participants	29.3 Years STANDARD_DEVIATION 7.0 • n=115 Participants	32.3 Years STANDARD_DEVIATION 5.6 • n=40 Participants	28.6 Years STANDARD_DEVIATION 4.6 • n=8 Participants	30.0 Years STANDARD_DEVIATION 6.5 • n=62 Participants	30.4 Years STANDARD_DEVIATION 7.2 • n=95 Participants	30.0 Years STANDARD_DEVIATION 6.6 • n=129 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	3 Participants n=483 Participants	3 Participants n=36 Participants	3 Participants n=10 Participants	9 Participants n=115 Participants	9 Participants n=40 Participants	9 Participants n=8 Participants	6 Participants n=62 Participants	14 Participants n=95 Participants	74 Participants n=129 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	3 Participants n=483 Participants	3 Participants n=36 Participants	3 Participants n=10 Participants	9 Participants n=115 Participants	9 Participants n=40 Participants	9 Participants n=8 Participants	6 Participants n=62 Participants	14 Participants n=95 Participants	74 Participants n=129 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants
Race (NIH/OMB) Asian	6 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	3 Participants n=483 Participants	3 Participants n=36 Participants	3 Participants n=10 Participants	9 Participants n=115 Participants	9 Participants n=40 Participants	9 Participants n=8 Participants	6 Participants n=62 Participants	14 Participants n=95 Participants	74 Participants n=129 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants

PRIMARY outcome

Timeframe: Up to 7 days (for SRD part), up to 17 days (for MD part).

Population: Treated set (TS): The treated set includes all subjects who were randomised (SRD and MD part) and treated with at least one dose of trial drug. As pre-specified in the protocol this endpoint only includes the SRD and MD part of the study.

Number of participants with drug-related adverse events (AEs) is reported for Single rising dose (SRD) and Multiple dose (MD) parts is reported.

Outcome measures

Outcome measures
Measure	SRD Part: PM Subjects, BI1323495 10mg n=6 Participants Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 30mg n=6 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 100mg n=6 Participants Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 30mg n=3 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 70mg n=3 Participants Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 150mg n=3 Participants Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: Placebo n=9 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 placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 30mg BID n=9 Participants Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 60mg QD n=9 Participants Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication	MD Part: Placebo n=6 Participants This arm comprises all placebo treated participants in trial part MD, 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 from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.
SRD and MD Part: Number of Participants With Drug-related Adverse Events (AEs)	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, and 167h after start of BI 1323495 administration on both periods (1 and 2).

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

The area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. The statistical model used for the analysis of this endpoint was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.

Outcome measures

Outcome measures
Measure	SRD Part: PM Subjects, BI1323495 10mg n=13 Participants Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 30mg n=14 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 100mg Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 30mg Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 70mg Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 150mg Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	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 placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 30mg BID Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 60mg QD Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication	MD Part: Placebo This arm comprises all placebo treated participants in trial part MD, 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 from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.
DDI Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	757.8 hour * nanomol / liter (h*nmol/L) Standard Error NA The standard error is actually the geometric standard error and is equal to 1.054.	2558.3 hour * nanomol / liter (h*nmol/L) Standard Error NA The standard error is actually the geometric standard error and is equal to 1.052	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, and 167h after start of BI 1323495 administration on both periods (1 and 2).

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

Maximum measured concentration of BI 1323495 in plasma is reported. The statistical model used for the analysis of this endpoint was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.

Outcome measures

Outcome measures
Measure	SRD Part: PM Subjects, BI1323495 10mg n=14 Participants Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 30mg n=14 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 100mg Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 30mg Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 70mg Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 150mg Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	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 placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 30mg BID Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 60mg QD Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication	MD Part: Placebo This arm comprises all placebo treated participants in trial part MD, 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 from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.
DDI Part: Maximum Measured Concentration of BI 1323495 in Plasma (Cmax)	81.2 nanomol / liter (nmol/L) Standard Error NA The standard error is actually the geometric standard error and is equal to 1.072.	149.7 nanomol / liter (nmol/L) Standard Error NA The standard error is actually the geometric standard error and is equal to 1.072.	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 47h, 71h, 95h, 119h, 143h, and 167h after start of BI 1323495 administration on both periods (1 and 2).

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

The area under the concentration-time curve BI 1323495 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. The statistical model used for the analysis of this endpoint was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.

Outcome measures

Outcome measures
Measure	SRD Part: PM Subjects, BI1323495 10mg n=14 Participants Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 30mg n=14 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 100mg Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 30mg Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 70mg Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 150mg Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	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 placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 30mg BID Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 60mg QD Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication	MD Part: Placebo This arm comprises all placebo treated participants in trial part MD, 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 from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.
DDI Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	704.5 hour * nanomol / liter (h*nmol/L) Standard Error NA The standard error is actually the geometric standard error and is equal to 1.056.	2513.8 hour * nanomol / liter (h*nmol/L) Standard Error NA The standard error is actually the geometric standard error and is equal to 1.056.	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 48h, 72h, 96h after start of BI 1323495 administration. Additionally only in the PM group: at 120h, 144h, and 168h.

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

The area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.

Outcome measures

Outcome measures
Measure	SRD Part: PM Subjects, BI1323495 10mg n=5 Participants Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 30mg n=6 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 100mg n=6 Participants Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 30mg n=3 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 70mg n=3 Participants Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 150mg n=3 Participants Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	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 placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 30mg BID Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 60mg QD Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication	MD Part: Placebo This arm comprises all placebo treated participants in trial part MD, 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 from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.
SRD Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	776 hour * nanomol / liter (h*nmol/L) Geometric Coefficient of Variation 9.14	2140 hour * nanomol / liter (h*nmol/L) Geometric Coefficient of Variation 25.7	6700 hour * nanomol / liter (h*nmol/L) Geometric Coefficient of Variation 13.9	715 hour * nanomol / liter (h*nmol/L) Geometric Coefficient of Variation 55.0	4040 hour * nanomol / liter (h*nmol/L) Geometric Coefficient of Variation 25.6	3550 hour * nanomol / liter (h*nmol/L) Geometric Coefficient of Variation 42.2	—	—	—	—

SECONDARY outcome

Timeframe: Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 34h, 48h, 72h, 96h after start of BI 1323495 administration. Additionally only in the PM group: at 120h, 144h, and 168h.

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

Maximum measured concentration of BI 1323495 in plasma (Cmax) is reported.

Outcome measures

Outcome measures
Measure	SRD Part: PM Subjects, BI1323495 10mg n=6 Participants Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 30mg n=6 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 100mg n=6 Participants Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 30mg n=3 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 70mg n=3 Participants Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 150mg n=3 Participants Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	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 placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 30mg BID Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 60mg QD Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication	MD Part: Placebo This arm comprises all placebo treated participants in trial part MD, 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 from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.
SRD Part: Maximum Measured Concentration of BI 1323495 in Plasma (Cmax)	105 nanomol / liter (nmol/L) Geometric Coefficient of Variation 18.0	276 nanomol / liter (nmol/L) Geometric Coefficient of Variation 22.1	643 nanomol / liter (nmol/L) Geometric Coefficient of Variation 9.15	86.9 nanomol / liter (nmol/L) Geometric Coefficient of Variation 37.0	196 nanomol / liter (nmol/L) Geometric Coefficient of Variation 8.72	230 nanomol / liter (nmol/L) Geometric Coefficient of Variation 54.9	—	—	—	—

SECONDARY outcome

Timeframe: Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, after start of first dose BI 1323495 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 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

The area under the concentration-time curve of BI 1323495 in plasma over the time interval of 12 h after administration of the first dose (AUC0-12) is reported.

Outcome measures

Outcome measures
Measure	SRD Part: PM Subjects, BI1323495 10mg n=9 Participants Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 30mg n=9 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 100mg Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 30mg Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 70mg Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 150mg Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	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 placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 30mg BID Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 60mg QD Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication	MD Part: Placebo This arm comprises all placebo treated participants in trial part MD, 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 from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.
MD Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval of 12 h After Administration of the First Dose (AUC0-12)	1520 hour * nanomol / liter (h*nmol/L) Geometric Coefficient of Variation 15.4	2350 hour * nanomol / liter (h*nmol/L) Geometric Coefficient of Variation 15.1	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 3 hours (h) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, after start of first dose BI 1323495 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 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Maximum measured concentration of BI 1323495 in plasma (Cmax) after first dose is reported.

Outcome measures

Outcome measures
Measure	SRD Part: PM Subjects, BI1323495 10mg n=9 Participants Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 30mg n=9 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 100mg Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 30mg Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 70mg Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 150mg Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	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 placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 30mg BID Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 60mg QD Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication	MD Part: Placebo This arm comprises all placebo treated participants in trial part MD, 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 from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.
MD Part: Maximum Measured Concentration of BI 1323495 in Plasma (Cmax) After First Dose	303 nanomol / liter (nmol/L) Geometric Coefficient of Variation 14.0	431 nanomol / liter (nmol/L) Geometric Coefficient of Variation 15.2	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 15 minutes (min) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h (only for the 60mg qd administration) after last dose 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 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Area under the concentration-time curve of BI 1323495 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after last dose administration is reported. T for 30 mg bid is 12h, for 60 mg qd is 24h.

Outcome measures

Outcome measures
Measure	SRD Part: PM Subjects, BI1323495 10mg n=9 Participants Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 30mg n=9 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 100mg Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 30mg Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 70mg Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 150mg Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	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 placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 30mg BID Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 60mg QD Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication	MD Part: Placebo This arm comprises all placebo treated participants in trial part MD, 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 from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.
MD Part: Area Under the Concentration-time Curve of BI 1323495 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After Last Dose Administration.	2600 hour * nanomol / liter (h*nmol/L) Geometric Coefficient of Variation 20.0	4770 hour * nanomol / liter (h*nmol/L) Geometric Coefficient of Variation 17.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 15 minutes (min) before and 20min, 40min, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h (only for the 60mg qd administration) after last dose 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 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Maximum measured concentration of BI 1323495 in plasma (Cmax,ss) at steady state over a uniform dosing interval τ is reported. T for 30 mg bid is 12h, for 60 mg qd is 24h.

Outcome measures

Outcome measures
Measure	SRD Part: PM Subjects, BI1323495 10mg n=9 Participants Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 30mg n=9 Participants Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 100mg Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 30mg Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 70mg Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 150mg Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	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 placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 30mg BID Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 60mg QD Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication	MD Part: Placebo This arm comprises all placebo treated participants in trial part MD, 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 from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.
MD Part: Maximum Measured Concentration of BI 1323495 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)	417 nanomol / liter (nmol/L) Geometric Coefficient of Variation 17.1	570 nanomol / liter (nmol/L) Geometric Coefficient of Variation 19.7	—	—	—	—	—	—	—	—

Deaths: 0 deaths

DDI Part: PM Subjects, BI1323495+ Itraconazole

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SRD Part: Placebo n=9 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 placebo film-coated tablet(s) together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: Placebo n=6 participants at risk This arm comprises all placebo treated participants in trial part MD, 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 from Day 1 to Day 11 one time per day (qd) an oral dose of placebo film-coated tablets or two times per day (bid) an oral dose of placebo together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 10mg n=6 participants at risk Participants were administered on Day 1 a single oral dose of 10 milligram (mg) of BI 1323495 film-coated tablet together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 30mg n=6 participants at risk Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: PM Subjects, BI1323495 100mg n=6 participants at risk Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 30mg n=3 participants at risk Participants were administered on Day 1 a single oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 70mg n=3 participants at risk Participants were administered on Day 1 a single oral dose of 70 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	SRD Part: EM Subjects, BI1323495 150mg n=3 participants at risk Participants were administered on Day 1 a single oral dose of 150 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. A standardized meal was served 30 minutes (min) before drug administration. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 30mg BID n=9 participants at risk Participants were administered from Day 1 to Day 10 two times per day (bid) an oral dose of 30 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water, At Day 11 participants were administered only a single dose in the morning. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. Morning and evening dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase. One authorized employee of the trial site was witness of the administration of the trial medication.	MD Part: PM Subjects, BI1323495 60mg QD n=9 participants at risk Participants were administered from Day 1 to Day 11 one time per day (qd) an oral dose of 60 milligram (mg) of BI 1323495 film-coated tablets together with about 240 milliliter (mL) of water. Participants took a normal caloric meal 30 minutes (min) before drug administration. Subjects fasted for 4 hours (h) after intake of morning dose. One authorized employee of the trial site was witness of the administration of the trial medication.	DDI Part: PM Subjects, BI1323495 n=14 participants at risk During period 1, participants were administered the reference treatment (R) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 together with about 240 milliliter (mL) of water on Day 1 of Period 1. One authorized employee of the trial site was witness of the administration of the trial medication. Administration of BI 1323495 in treatment R and T were separated by at least 11 days.	DDI Part: PM Subjects, Itraconazole n=14 participants at risk During period 2, participants were administered the test treatment (T) which consisted of multiple oral doses of 200 mg itraconazole from Day -3 to Day 7, in total 10 doses, as oral solution formulation, together with of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 with about 240 milliliter (mL) of water on Day 1 of Period 2. Administration of BI 1323495 in treatment R and T were separated by at least 11 days.	DDI Part: PM Subjects, BI1323495+ Itraconazole n=14 participants at risk During period 2, participants were administered the test treatment (T) which consisted of a single oral dose of 10 milligram (mg) film-coated tablet of BI 1323495 with about 240 milliliter (mL) of water on Day 1 of Period 2, together with multiple oral doses of 200 mg itraconazole from Day -3 to Day 7, in total 10 doses, as oral solution formulation. Administration of BI 1323495 in treatment R and T were separated by at least 11 days.
Skin and subcutaneous tissue disorders Rash	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	16.7% 1/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.
Gastrointestinal disorders Diarrhoea	11.1% 1/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	16.7% 1/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	16.7% 1/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	16.7% 1/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	50.0% 3/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	33.3% 1/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	33.3% 1/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	11.1% 1/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	44.4% 4/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	28.6% 4/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	7.1% 1/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.
Gastrointestinal disorders Constipation	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	16.7% 1/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.
Gastrointestinal disorders Abdominal distension	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	11.1% 1/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.
Gastrointestinal disorders Oesophageal discomfort	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	11.1% 1/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	33.3% 1/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.
Nervous system disorders Dysgeusia	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	7.1% 1/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.
Nervous system disorders Hypoaesthesia	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	7.1% 1/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.
Nervous system disorders Syncope	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	7.1% 1/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.
Nervous system disorders Headache	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	16.7% 1/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.
General disorders Pyrexia	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	11.1% 1/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.
General disorders Sensation of foreign body	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	7.1% 1/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.
Infections and infestations Oral herpes	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/6 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/3 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	11.1% 1/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/9 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.	0.00% 0/14 • Up to 7 days for the SRD part, Up to 17 days for the MD part, Up to 7 days for the DDI-BI 1323495, Up to 3 days for the DDI-itraconazole, Up to 15 days for the DDI-BI1323495.+ itraconazole. Treated set (TS): The treated set includes all subjects who were randomized (SRD and MD part) / allocated (DDI part) and treated with at least one dose of trial drug. The Adverse Event assessment was reported for the DDI part: BI 1323495 (Period 1), subsequently the Itraconazole treatment and, for BI 1323495+Itraconazole treatment separately.

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