Clinical trial: Study in Healthy Adults to Quantify Lung Deposition and Distribution of Radio-labelled S-770108 Inhalation Powder Formulation Delivered by a Novel Inhaler Device (NCT04631354)

Eligibility criteria:
Inclusion Criteria:

          1. Subjects who are able to understand this study and comply with all study procedures,
             are able to be trained and use the device correctly at screening and willing to
             provide written informed consent before screening.

          2. Subjects judged to be healthy by the principal or sub investigator, based on medical
             history and clinical evaluation.

          3. Male and female subjects ≥ 40 to ≤ 80 years of age at the time of informed consent.

          4. Subjects whose body mass index (BMI) is ≥ 18.0 and < 30.0 kg/m2 during the screening
             visit．

          5. Subjects able to produce a peak inspiratory flow rate of at least 30.00L/min at
             screening using the investigational device attached to an electronic flow meter.

          6. Subjects who have smoked within 12 months before admission cannot be entered the
             study.

          7. Subjects judged to have normal lung function. Specifically, with percent predicted
             forced expiratory volume in 1 second (%FEV1) ≥ 80% and forced expiratory volume in 1
             second (FEV1)/forced vital capacity (FVC) ratio ≥70%.

          8. Male subjects are eligible to participate if they agree to the following during the
             treatment period and for at least 3 months (a spermatogenesis cycle) after the last
             dose of study intervention.

               -  Refrain from donating sperm.

               -  Must agree to use a male condom and should also be advised of the benefit for a
                  female partner to use a highly effective method of contraception as described in
                  Appendix 2, as a condom may break or leak when having sexual intercourse with a
                  woman of childbearing potential who is not currently pregnant.

          9. Female subjects who agree to use of appropriate contraception measures from time of
             screening until 3 months after the last dose of study drug, except for female subjects
             who are surgically sterile by bilateral oophorectomy for at least 6 weeks with
             appropriate documentation or who are post-menopausal (defined as at least 6 months of
             spontaneous amenorrhea in woman > 45 years with serum follicle-stimulating hormone
             (FSH) levels > 40 mIU/mL at screening, or at least 12 months of spontaneous amenorrhea
             in woman > 45 years)

        Exclusion Criteria:

          1. Subjects deemed by the principal or sub investigator to be ineligible for the study
             due to history of, or concurrent and clinically significant metabolic or endocrine,
             hepatic, renal, haematological, respiratory, cardiovascular, gastrointestinal,
             urological, immunological, neurological or psychiatric disorders, or any malignant
             neoplasms at any diagnosed stage.

          2. Radiation exposure, including that from the present study, excluding background
             radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv
             in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker,
             as defined in the Ionising Radiation Regulations 2018, shall participate in the study.

          3. Subjects who have a history of clinically relevant respiratory disease, diseases
             affecting respiratory function, E.N.T. diseases, or lung surgery.

          4. Subjects who have had an upper respiratory infection in the last 7 days which could
             affect inhalation/absorption of study medication.

          5. Subjects who use regular medication (prescribed and/or over the counter) or have used
             any medication (excluding non-prescription drugs, vitamins, and dietary or herbal
             supplements which do not interfere with respiratory function according to their
             labelling) within 14 days before admission; exceptions may be permitted on a case by
             case basis if considered not to interfere with the aims of the study and agreed by the
             investigator and sponsor's medical monitor.

          6. Subjects with a history of lactose intolerance, intolerance to dairy products, or a
             history of gluten intolerance.

          7. Subjects with a history of serious adverse reaction or serious hypersensitivity to the
             active ingredient or excipients in any drug.

          8. Subjects with a history of drug and/or alcohol addiction within the past 2 years
             before screening or a positive test for drugs or alcohol at screening or admission
             visit.

          9. Regular alcohol consumption in males of > 21 units per week, or females of > 14 units
             per week (1 unit = 1/2 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).

         10. Subjects with a positive result on any of the tests for the serologic detection of
             human immunodeficiency virus (HIV) antigen/antibody, hepatitis B surface antigen
             (HBsAg), and hepatitis C antibody.

         11. Female subjects who are pregnant, breast-feeding, have a positive pregnancy test
             result during the screening assessment or admissions; or intending to become pregnant
             during the study period or within 3 months after the last dose of study treatment.

         12. Subjects who have donated > 400 mL of blood within 3 months before screening, > 200 mL
             within 4 weeks before screening, or who donated blood between screening and admission.

         13. Subjects who have been exposed to an investigational drug within 90 days prior to
             study drug administration.

         14. Subjects who have previously received pirfenidone (Esbriet®, Pirespa®) in any form, or
             S 770108.

         15. Subjects who are study site employees or immediate family members of a study site
             employee, or sponsor employees.

         16. Subjects who are ineligible for the study for any other reason, as judged by the
             investigator or sub investigator.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 80 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? Contradiction