A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 730357 in the Blood
Condition: Healthy
Intervention: BI 730357; Itraconazole
Intervention description: 0 mg BI 730357 tablet orally on Day 1; 20 mL of 10 mg/ mL Itraconazole oral solution in treatment period 2 only (T). Itraconazole was administered once daily for 12 days from Day -3 to Day 9.
Intervention MeSH terms: Itraconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main objective of this trial is to investigate the relative bioavailability of BI 730357
      in plasma when given as oral single dose together with multiple oral doses of itraconazole
      (Test, T) as compared to when given alone as oral single dose (Reference, R)
    

Eligibility criteria:

        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 (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 Good Clinical Practice (GCP) and local legislation

        Exclusion Criteria:

          -  Any finding in the medical examination (including blood pressure (BP), pulse rate (PR)
             or Electrocardiogram (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

          -  Chronic or relevant acute infections

          -  History of relevant allergy or hypersensitivity (including allergy to the trial
             medication or its excipients)

          -  Use of drugs within 30 days of planned administration of trial medication that might
             reasonably influence the results of the trial (including drugs that cause QT/QTc
             interval prolongation)

          -  Intake of an investigational drug in another clinical trial within 60 days of planned
             administration of investigational drug in the current trial, or concurrent
             participation in another clinical trial in which investigational drug is administered

          -  Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)

          -  Inability to refrain from smoking on specified trial days

          -  Alcohol abuse (consumption of more than 30 g per day)

          -  Drug abuse or positive drug screening

          -  Blood donation of more than 100 mL within 30 days of planned administration of trial
             medication or intended blood donation during the trial

          -  Intention to perform excessive physical activities within one week prior to the
             administration of trial medication or during the trial

          -  Inability to comply with the dietary regimen of the trial site

          -  A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are
             repeatedly greater than 450 ms) or any other relevant Electrocardiogram (ECG) finding
             at screening

          -  A history of additional risk factors for Torsade de Pointes (such as heart failure,
             hypokalaemia, or family history of Long QT Syndrome)

          -  Subject is assessed as unsuitable for inclusion by the investigator, for instance,
             because the subject is not considered able to understand and comply with study
             requirements, or has a condition that would not allow safe participation in the study

        In addition, the following trial-specific exclusion criteria apply:

          -  Liver enzyme (ALT, AST, GGT) values above upper limit of normal at the screening
             examination

          -  History of drug-induced liver injury

          -  History of heart failure, or any evidence of ventricular dysfunction in the history

          -  History of hereditary fructose intolerance

          -  Male subjects with WOCBP partner who are unwilling to use male contraception (condom
             or sexual abstinence) from time point of first administration of trial medication
             until 30 days after the last administration of trial medication

          -  Further exclusion criteria apply