Clinical trial: Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China (NCT03288636)

Eligibility criteria:
Inclusion Criteria:

          -  Age between 18-45 years old;

          -  Male body weight not less than 50kg; Female body weight not less than 45kg; BMI in the
             range of 19~28kg/m2

          -  Healthy men or women based on history, physical examination, laboratory examination
             and ECG.

          -  Female subjects should be surgically sterilized (bilateral tubal ligation, bilateral
             ovariectomy or hysterectomy); or are willing to use at least one of the following
             contraceptive methods within 30 days of the first administration of the study drug
             until the last administration: I Male partner vas deferens ligation; II. Non-hormonal
             contraceptive methods: intrauterine contraceptives, condoms, contraceptive sponges,
             septa, vaginal ring containing sizing gel or cream.

          -  Male subjects should be surgically sterilized; or are willing to use at least one of
             the following contraceptive methods within 30 days from the first administration of
             the study to the last administration: I. Female partners abstinence during the study
             period (including no donation): II. Compounds use hormonal contraceptives (oral,
             vaginal, parenteral or transdermal); III. Subjects and / or their female partners use
             non-hormonal contraceptive methods: condoms, contraceptive sponges, membranes,
             intrauterine devices, Fine gel or cream of the vaginal ring.

          -  If female, the pregnancy test result should be negative during the screening period.

          -  Voluntary to sign the informed consent.

        Exclusion Criteria:

          -  History or presence of cardiovascular disease, respiratory disease, endocrine and
             metabolic system disease, urinary system, digestive system, hematological system
             diseases, nervous system or Psychiatric diseases, and acute or chronic infectious
             disease and malignant tumor.

          -  A history of drug or food allergy.

          -  Positive test in any of the HBsAg、HCV Ab、HIV Ab and Syphilis Ab.

          -  Any of the AST、ALT、ALP、TBIL and DBIL exceed the upper limits of normal, or other
             laboratory test results exceeding the normal range and judged by the investigator to
             be clinically significant.

          -  History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other
             surgeries that could disturb gastrointestinal motility and PH absorption.

          -  Female who were during pregnancy, breastfeeding, period and unwilling to take reliable
             birth control method.

          -  Female partners were fertile and unwilling to take reliable contraceptive measures.

          -  Others as specified in the detailed protocol.
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 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? Contradiction