Health subjects
Conditions
Interventions
A group:Group A subjects took KL590586 capsules orally on an empty stomach in the first cycle
A group: Subjects in group A took KL590586 capsules orally in the postprandial state in the second cycle
B group:Subjects in group B took KL590586 capsules orally in the postprandial state in the first cycle
B group:Group B subjects took KL590586 capsules orally on an empty stomach in the second cycle
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 and = 55 years old at the time of signing the informed consent form, regardless of gender; 2. Male subjects weighed = 50.0 kg, female subjects weighed = 45.0 kg, 18.5 kg/m2= body mass index [BMI = weight (kg) / height 2 (m2)]= 25.0 kg/m2; 3. During the study period and within 6 months after the last dose, fertile subjects (both men and women) must use effective medical contraception (see Annex 3 for specific contraceptive measures); 4. Subject voluntarily joins the study, signs informed consent, and is able to follow the visit and related procedures prescribed in the protocol.
Exclusion criteria
Exclusion criteria: 1. Those who are prone to allergic reactions, or allergic constitutions (such as allergies to pollen, two or more drugs/foods), or those who are known to be allergic to the components of this drug; 2. Those with a history of malignant tumors; 3. Those with mental or neurological disorders who cannot fully understand and cooperate; 4. Have a history of recurrent chronic infection in the past, or have any infection that the investigator determines to be clinically significant within 3 months before randomization; 5. Those who have previously suffered from serious diseases such as the digestive system, circulatory system, respiratory system, urinary system or existing above diseases (such as severe liver damage, interstitial lung disease, etc.), or new diseases before the use of study drugs, and who are not suitable to participate in this study after the investigator's assessment; 6. Those who have previously suffered from serious blood system diseases (such as aplastic anemia, myelodysplastic syndrome, etc.), or have any diseases that can cause hemolysis or red blood cell instability (such as malaria, hemolytic anemia, etc.) within 3 months before randomization; 7. Heart failure (NYHA standard grade II.~IV.), unstable angina, myocardial infarction, persistent and clinically significant arrhythmia, significant QTc interval prolongation (450 ms for men >and 470 ms for women> and/or stroke, transient ischemic attack, etc. within 3 months of randomization, researchers believe that there is an additional risk to the study drug; 8. Those with aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > upper limit of normal value (ULN), total bilirubin (TBIL), UL>N, serum creatinine (SCr) > ULN during the screening period, or abnormalities such as physical examination, vital sign examination, chest X-ray, abdominal ultrasound, electrocardiogram, clinical laboratory examination, etc., and are judged by the investigator to have clinical significance; 9. In the case of no drugs affecting blood pressure during the screening period: systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 60 mmHg, or systolic blood pressure = 140 mmHg and/or diastolic blood pressure = 90 mmHg, and the investigator judged to have clinical significance; 10. Hepatitis B surface antigen positive, or hepatitis B surface antigen negative and hepatitis B core antibody positive when the hepatitis B virus DNA is higher than the lower limit of detection; Hepatitis C antibody positive person; HIV-positive people; Those who have a positive syphilis antibody test; 11. Those with a history of dysphagia or any gastrointestinal disease that may affect the absorption of drugs; 12. Those with a history of drug abuse or positive urine drug screening during the screening period; 13. Those who have received selective RET inhibitors (including marketed and clinical trial drugs, such as Selpercatinib/LOXO-292, Pralsetinib/BLU-667, SY-5007, etc.) or any other similar structural drugs within 3 months before randomization; 14. Those who have participated in clinical trials of any drug or medical device within 3 months before randomization and have received the experimental drug (including placebo control group) or medical device treatment; 15. Those who have used other drugs within 7 days before randomization, including prescription drugs, over-the-counter drugs, Chinese herbal medicines and health care products, or those who have used any drugs that may interact with thi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8;Tmax;Vz/F;CL/F;?z;t1/2; | — |
Secondary
| Measure | Time frame |
|---|---|
| security; | — |
Countries
China
Contacts
Public ContactPing Feng
West China Hospital of Sichuan University
Outcome results
None listed