To investigate the pharmacokinetics of a single oral dose of BI 706321 when given alone or in combination with itraconazole.

Inclusion Criteria:

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (body temperature, blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 50 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
• Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

Exclusion Criteria:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection Further exclusion criteria apply.

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder;
2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

Treated set (TS): The TS included all subjects who were treated with at least 1 dose of study drug.

BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.

Continuation of time frames:

Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d.

Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d.

Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.