Clinical trial: Repeat Doses of BAY 1817080 in Healthy Males & Proof of Concept in Chronic Cough Patients (NCT03310645)

Eligibility criteria:
Inclusion Criteria:

        Part 1

          -  Male; healthy according to complete medical history, including the physical
             examination, vital signs (blood pressure, pulse rate), 12 lead ECG, clinical
             laboratory tests.

          -  Age: 18-45 years (inclusive) at the first screening visit

          -  Non-smoker for at least the past 6 months and with a pack year history of equal to or
             less than 5 years.

          -  Subjects who are sexually active and have not been surgically sterilized must agree to
             use two reliable and acceptable methods of contraception simultaneously when having
             sexual intercourse with women of childbearing potential (one method used by the
             subject and one method used by the partner) during the study and for 90 days after
             receiving the investigational medicinal product and not to act as sperm donor for 90
             days after dosing. [Acceptable methods of contraception include for example: (a)
             condoms (male or female) with or without a spermicidal agent, (b) diaphragm or
             cervical cap with spermicide, (c) intrauterine device, (d) hormone-based
             contraception.

        Part 2:

          -  Age: >18 years at the first screening visit

          -  Refractory chronic cough for at least one year:

               -  that has been shown to be unresponsive to at least 8 weeks of targeted treatment
                  for identified underlying triggers including reflux disease, asthma and
                  post-nasal drip or unexplained cough, and

               -  for which no objective evidence of an underlying trigger can be determined after
                  investigation.

          -  Score of >40 mm on the Cough Severity visual analogue scale (VAS) at screening.

          -  For male patients:

        Male patients who are sexually active and have not been surgically sterilized must agree to
        use two reliable and acceptable methods of contraception simultaneously (one method used by
        the study patient and one method used by the partner) during the study and for 90 days
        after receiving the investigational medicinal product and not to act as sperm donor for 90
        days after dosing. [Acceptable methods of contraception include for example: (a) condoms
        (male or female) with or without a spermicidal agent, (b) diaphragm or cervical cap with
        spermicide, (c) intrauterine device, (d) hormone-based contraception.

        --For female patients: Confirmed post-menopausal woman (defined as exhibiting spontaneous
        amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea
        for 6 months before screening with documented serum follicle-stimulating hormone (FSH)
        levels > 40 mIU/mL) or Woman without childbearing potential based on surgical treatment at
        least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy
        with or without hysterectomy (documented by medical report verification) or Woman of
        childbearing potential that agrees to use two reliable and acceptable methods of
        contraception simultaneously (one method used by the study patient and one method used by
        the partner) during the study and for at least 10 days after the last dose. Acceptable
        methods of contraception include for example: (a)condoms (male or female) with or without a
        spermicidal agent (b)diaphragm or cervical cap with spermicide (c) intrauterine device
        (d)hormone-based contraception.

        Exclusion Criteria:

        Part 1

          -  Relevant diseases potentially interfering with the study's aims (e.g.respiratory
             diseases) within the four weeks before screening or between screening and
             randomization

          -  Any febrile illness within the four weeks before screening or between screening and
             randomization

          -  Medical history of hypogeusia/dysgeusia or the subject has a dysfunction in his/her
             ability to taste, as revealed by the taste disturbance questionnaire during screening
             and the pre dose procedures

          -  Use of any over-the-counter cough mixture within the 24 hours before screening

        Part 2:

          -  FEV1 or FVC of less than 60% of predicted normal, at screening

          -  History of upper or lower respiratory tract infection or recent significant change in
             pulmonary status within the 4 weeks before baseline visit

          -  Current smoking habit or history of smoking within the 6 months before the screening
             visit.

          -  History of smoking (at any time) for more than 20 pack-years in total (20 cigarettes
             per pack)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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? Entailment