Clinical trial: Multiple Rising Inhalative Doses of BI 1744 CL in Healthy Male Volunteers (NCT02172105)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy Japanese men: According to the results of a complete medical history, the
             physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG,
             clinical laboratory tests

          -  Age ≥20 and ≤35 years

          -  Body mass index (BMI) ≥18.5 and ≤25.0 kg/m2

          -  Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice and the local legislation

          -  Subjects must be able to inhale medication in a competent manner from the
             Respimat®inhaler

        Exclusion Criteria:

          -  Any finding of the medical examination (including ,blood pressure and pulse rate and
             ECG) deviating from normal and of clinical relevance

          -  Any evidence of a clinically relevant concomitant disease

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Surgery of the gastrointestinal tract (except appendectomy)

          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or
             neurological disorders

          -  History of relevant orthostatic hypotension, fainting spells or blackouts

          -  Chronic or relevant acute infections

          -  History of relevant allergy/hypersensitivity (including allergy to drug or its
             excipients)

          -  Intake of drugs with a long half-life (>24 hours) within at least one month or less
             than 10 half-lives of the respective drug before drug administration or during the
             trial

          -  Use of prescription or non-prescription drugs within 10 days before drug
             administration or during the trial. However, over-the-counter drugs for external
             application (such as lubricant eye drops for contact lens, insect bite reliever) shall
             be allowed

          -  Participation in another trial with an investigational drug within four months before
             drug administration or during the trial

          -  Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)

          -  Inability to refrain from smoking on trial days

          -  Alcohol abuse (more than 60 g/day: corresponds to ca. 3 large bottles of beer, 3 gous
             (ca. 540 cc) of Japanese sake, 6 shots of whisky, 6 glasses of wine or 6 glasses of
             Japanese shochu, distilled alcoholic beverage)

          -  Drug abuse

          -  Blood donation (more than 100 mL within four weeks before drug administration or
             during the trial)

          -  Excessive physical activities (within one week before administration or during the
             trial)

          -  Any laboratory value outside the reference range that is of clinical relevance

          -  Inability to comply with dietary regimen of trial site

          -  A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a
             QTc interval >450 ms) or long QT syndroms

          -  A history of additional risk factors for torsades de pointes (TdP) (e.g., heart
             failure, hypokalemia) or other cardiac arrhythmias

          -  hyperthyroidism

          -  Disagree with adequate contraception (the subject should use condoms and his partner
             should use oral contraception or intrauterine device [IUD]) during the study
Male
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 35 Years

Patient description (medical language): A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications.  Vital signs are normal.  On physical examination, the patient is tall with long upper extremities and fingers.  The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw.  The lungs are clear on auscultation.  The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver.

Patient description (patient's own words): I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since.

Does the patient match the trial criteria? Contradiction