Clinical trial: A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1358894 in the Blood (NCT03843151)

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 45 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

          -  Willingness to comply with contraception requirements. Subjects who are sexually
             active must use adequate contraception with their female partner throughout the study
             and until 1 month after the last administration of trial medication. Adequate methods
             are:

               -  Sexual abstinence or

               -  A vasectomy performed at least 1 year prior to screening (with medical assessment
                  of the surgical success) or

               -  Surgical sterilisation (including bilateral tubal occlusion, hysterectomy or
                  bilateral oophorectomy) of the subject's female partner or

               -  The use of condoms, if the female partner uses an adequate contraception method
                  in addition, e.g., intrauterine device (IUD), hormonal contraception (e.g.
                  implants, injectables, combined oral or vaginal contraceptives) that started at
                  least 2 months prior to first drug administration, or barrier method (e.g.
                  diaphragm with spermicide) Unprotected sexual intercourse with a female partner
                  is not allowed throughout the study and until 1 month after the last
                  administration of trial medication.

        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 50 to 90 beats per minute (bpm)

          -  C-reactive protein (CRP)> Upper limit of normal (ULN), Erythrocyte sedimentation rate
             (ESR)≥15 millimeters/h, liver or kidney parameter above ULN, or any other 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
             medications or their 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)

          -  Participation in another trial where an investigational drug has been administered
             within 60 days prior to planned administration of trial medication, or current
             participation in another trial involving administration of investigational drug

          -  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 in males) or any other relevant 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

          -  Any lifetime history of suicidal behaviour (i.e. actual attempt, interrupted attempt,
             aborted attempt, or preparatory acts or behaviour)

          -  Any suicidal ideation of type 2 to 5 on the Columbia Suicide Severity Rating Scale
             (C-SSRS) in the past 12 months (i.e. active suicidal thought, active suicidal thought
             with method, active suicidal thought with intent but without specific plan, or active
             suicidal thought with plan and intent)

          -  Any history of drug-induced liver failure.

          -  History of ventricular dysfunction or congestive heart failure.

          -  Further exclusion criteria apply
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? 0