Clinical trial: Lung Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF) (NCT03524066)

Eligibility criteria:
Inclusion Criteria:

          -  Male and female subjects, aged 18-50 years. Women will be considered for inclusion if
             they are: Not pregnant, as confirmed by pregnancy test (see flow chart), and not
             nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming
             pregnant, including any female who is pre-menarchial or post-menopausal, with
             documented proof of hysterectomy or tubal ligation, or meets clinical criteria for
             menopause and has been amenorrhoeic for more than 1 year prior to the screening
             visit). Of childbearing potential and using a highly effective method of contraception
             during the entire study (vasectomised partner, sexual abstinence - the lifestyle of
             the female should be such that there is complete abstinence from intercourse from two
             weeks prior to the first dose of study medication until at least 72 hours after
             treatment -, implants, injectables, combined oral contraceptives, hormonal IUDs
             (Intrauterine devices) or double-barrier methods, i.e. any double combination of IUD,
             condom with spermicidal gel, diaphragm, sponge, and cervical cap).

          -  Normal lung function with Forced Expiratory Volume in the first second (FEV1)
             predicted ≥ 80% and FEV1/Forced Vital Capacity (FVC) > 70%.

          -  Nonsmokers with a history of less than 1 pack year having been nonsmokers for at least
             the last five years

          -  Body mass index between 18 and 32 kg/m²

          -  Able and willing to give written informed consent.

        Exclusion Criteria:

          -  Past or present disease, which as judged by the investigator, may affect the outcome
             of the study. These diseases include, but are not limited to, cardiovascular disease,
             malignancy, hepatic disease, renal disease, hematological disease, neurological
             disease, psychiatric disease, endocrine disease, infectious disease, inflammatory
             disease or pulmonary disease (including but not confined to asthma, tuberculosis,
             bronchiectasis or cystic fibrosis)

          -  Regular intake of any prescribed or over the counter medication. Exceptions include
             paracetamol for pain relief, oral contraceptive medication, hormonal replacement
             therapy, dietary and vitamin supplements

          -  Clinically relevant history of allergy as judged by the investigator

          -  Intolerance or contraindications to medications applied as model drugs (e.g.
             hyperthyreosis) or for sedation during bronchoscopy

          -  Infections of the lower respiratory tract within 4 weeks before visit 1, visit 2, or
             visit 3. These patients can be rescreened starting from visit 1.

          -  Any clinically relevant abnormal findings in physical examination, clinical chemistry,
             hematology, urinalysis, vital signs, lung function, or ECG at Visit 1, which, in the
             opinion of the investigator, may either put the subject at risk because of
             participation in the study, or may influence the results of the study, or the
             subject's ability to participate in the study

          -  History of drug or alcohol abuse

          -  Risk of non-compliance with study procedures

          -  Suspected inability to understand the protocol requirements, instructions and
             study-related restrictions, the nature, scope, and possible consequences of the study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 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