| Eligibility |
Inclusion Criteria:
1. Signing the informed consent forms;
2. Healthy adult males;
3. Age: 18 Years to 45 Years(Including the boundary value);
4. Weight: Body mass index(BMI) between 19 and 26 kg/m2(Including the boundary value);
Exclusion Criteria:
Candidates who meet any of the following conditions will not be selected:
Laboratory examination:
1. Complete physical examination, laboratory examination (blood routine, blood
biochemistry, urine routine, coagulation function, fecal occulted blood, thyroid
function (FT3, FT4, TSH), 12-lead electrocardiogram, X-chest X-ray (orthostatic
position), abdominal B-ultrasound (liver, bile, pancreas, spleen, kidney) and other
abnormal and clinically significant examinations;
2. Ophthalmologic examination (slit lamp, intraocular pressure and fundus photography)
with abnormal clinical significance;
3. Hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and
syphilis antibody, any of which are positive.
Medical history:
4. Screening for use of any clinical trial drug within the first 3 months or withdrawal
time shorter than the 6 half-life period of the trial drug at enrollment, whichever is
the longest of the two;
5. CYP3A4, CYP2C8 and CYP2C9 inducers or inhibitors were taken within 28 days before
screening, as shown in Appendix 1.
6. Use of any prescription or over-the-counter drug, any vitamin product, health care
drug or Chinese herbal medicine within 14 days prior to screening;
Medical history and treatment history:
7. clinical symptoms or diseases of the heart that cannot be well controlled, such as
:(1) heart failure of NYHA2 or above; (2) unstable angina pectoris; (3) myocardial
infarction within 1 year; (4) supraventral or ventricular arrhythmia with clinical
significance that requires treatment or intervention; (5) QTcF>450ms(male) at
screening stage; (5) QTcF>450ms.
8. Patients who had undergone major surgery or whose surgical incision was not completely
healed within 6 months before the screening period;Major surgery includes, but is not
limited to, any surgery with a significant risk of bleeding, prolonged general
anesthesia, or an open biopsy or significant traumatic injury;
9. Screening for abdominal fistula, gastrointestinal perforation or abdominal abscess in
the first 6 months;
10. Screening for clinically significant bleeding symptoms or definite bleeding tendency,
such as gastrointestinal bleeding and bleeding ulcer, in the first 3 months;
11. Hemorrhoids or perianal diseases with regular/bleeding in the stool;Patients with
gastrointestinal dysfunction, such as irritable bowel syndrome and inflammatory bowel
disease, may be affected by drug absorption as determined by researchers;
12. Allergic persons, including those with a history of severe drug allergy or drug
allergy, and those with known allergy to SHR6390 or similar drugs and
excipients;Allergic to any food ingredients or has special requirements on diet,
cannot follow the unified diet;
13. A history of any clinically serious illness or condition, including but not limited to
circulatory, endocrine, nervous, digestive, urinary, or blood, immune, mental, and
metabolic diseases, that the investigator considers to be likely to affect the results
of the study;
Living Habits:
14. Habitual constipation or diarrhea;
15. Heavy drinking or regular drinking in the six months preceding the screening period,
i.e. drinking more than 14 units of alcohol per week (1 unit =285 mL beer or 25 mL
spirits of 40% alcohol or 100 mL wine);Or alcohol breath test results at screening
period =20 mg/ dL;
16. Those who had smoked more than 5 cigarettes per day on average in the 3 months before
the screening period or habitually used nicotine-containing products and were unable
to quit during the test period;
17. Substance abuse or use of soft drugs (e.g., marijuana) in the 3 months prior to the
screening period or use of hard drugs (e.g., cocaine, amphetamines,
phenylcyclohexidine, etc.) in the 1 year prior to the screening period;Or screening
for positive urine drug abuse (drug) tests;
18. habitual consumption of grapefruit juice or excessive consumption of tea, coffee
and/or caffeinated beverages and failure to abstain during the study period;
Other:
19. Those with a history of fainting needle or blood, have difficulty in blood collection
or cannot tolerate vein puncture for blood collection;
20. Workers engaged in conditions requiring long-term exposure to radioactivity;Or have
significant radiation exposure (=2 chest/abdomen CT, or =3 other types of X-ray
examinations) within 1 year before the test or have participated in the
radiopharmaceutical labeling test;
21. Having family planning during the trial period and within 12 months after the last use
of the drug, or not agreeing that subjects and their spouses should take strict
contraceptive measures during the trial period and within 12 months after the last use
of the drug (see Appendix 2);
22. Those who have lost blood or donated up to 400 mL within 3 months before the screening
period, or those who have received blood transfusion, or those who plan to donate
blood within 1 month after the end of this test;
23. As determined by the investigator, the subject has other factors that are not suitable
for the study.
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