Studies Evaluating the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of TY-9591 Tablets in Healthy Subjects

To evaluate the pharmacokinetics of TY-9591 tablets in healthy Chinese subjects after a single oral administration. To evaluate the effects of itraconazole/rifampicin on the pharmacokinetics of TY-9591 and its metabolites D1 and D2 after oral administration of TY-9591 tablets.

Inclusion criteria

• Male or female healthy adult subjects aged 18-45 years old (inclusive), in which male or female accounted for no less than 1/4 of the total number of subjects in each sequence.
• Body mass index (BMI) between 19.0 and 26.0 kg/m2 [BMI= weight (kg)/ height 2 (m2)] (including boundary values).
• Participants (including male participants) were infertile themselves, or agreed to use highly effective nonpharmacologic contraceptive methods or abstain completely from sex for 6 months after the last dose of self-medication.
• Subjects voluntarily participated and signed an informed consent form.
• Subjects had good communication with investigators and were able to complete the trial in accordance with the protocol.

Exclusion criteria

• Those with clinically significant abnormalities in physical examination, vital signs, routine laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), 12-lead electrocardiogram, ophthalmic examination, abdominal color Doppler ultrasound (liver, bile duct, pancreas, spleen, kidney), etc.
• Persons with one or more positive results of human immunodeficiency virus (HIV) antibody, hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, or treponema pallidum antibody (Anti-TP).
• smokers with an average of more than 10 cigarettes per day in the previous 3 months or habitual users of nicotine products who could not quit during the study.
• Heavy drinking or regular drinking in the 3 months before the screening period, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); Or alcohol breath test results on admission > 0.0 mg/100 mL and those who could not abstain from alcohol during the experiment.
• those who consumed excessive amounts of tea, coffee, and/or caffeinated beverages (average > 8 cups/day, 250 mL/cup) in the 3 months before the screening period, and those who could not stop using them during the study period.
• those who took dragon fruit, mango, grapefruit, chocolate, any food or beverage containing caffeine, diet rich in xanthine, and other special diets affecting drug absorption, distribution, metabolism, and excretion within 7 days before taking the drug.
• Use of any drugs that inhibit or induce the liver CYP3A4 enzyme (see Appendix II), herbs, or foods containing herbal ingredients within 30 days before the screening period.
• taking any medicine (including Chinese herbal medicine and health supplements) within 14 days before taking the test drug.
• enrollment in any drug clinical trial within 3 months before the screening period.
• Subjects who may not be able to complete the study for other reasons or who are considered unsuitable for the study by the investigators.