pulmonary tuberculosis
Conditions
Interventions
Healthy male subjects:The A study consists of two cycles: the first cycle D1 to D10, in which participants take WX-081 tablets orally once a day after breakfast, with a dose of 300 mg per dose
In the second cycle D11-D14, the subjects will take WX-081 (300 mg, once daily) and itraconazole capsules (200 mg, once daily) orally after breakfast. On the 11th day after dinner, they will take itra
Healthy male subjects:The B study consists of two cycles: the first cycle D1, in which the subjects take WX-081 tablets orally once after breakfast (regular meal) at a dose of 450 mg
In the second cycle D15~D27, the subjects will take rifampicin capsules orally once a day on an empty stomach, with a dose of 600 mg each time. For D22, in addition to taking rifampicin orally on an e
Healthy male subjects:The C study is a single dose study with two cycles. All subjects will take WX-081 tablets orally on an empty stomach on D1 of the first cycle, with a dose of 450 mg, followed by
On the first day of the second cycle (i.e. D15), after breakfast (high-fat meal), take WX-081 tablets orally again in a single dose of 450 mg.
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy male and female volunteers, aged 18 to 50 years old (including 18 and 50); 2. The weight of male subjects shall not be less than 50 kilograms, and the weight of female subjects shall not be less than 45 kilograms. Body mass index (BMI) is between 18-28 kg/m ² (including 18 and 28), BMI=weight (kg)/height ² (m ²); 3. Before the study, a comprehensive physical examination, 12 lead ECG examination, and vital signs were conducted, which were normal or abnormal but had no clinical significance. Among them: 12 lead ECG requires QTcF<450 ms; (A study PR interval<200 ms; QRS complex duration<120 ms; B. If a subject experiences a slightly longer PR before administration in study C, the researcher can determine whether to enroll the subject based on their safety risk; 4. The subjects (including partners) are willing to voluntarily adopt effective contraceptive measures from self screening until 6 months after the last administration of the study drug, as detailed in Appendix 1; 5. Understand and sign the informed consent form, and voluntarily participate in this experiment.
Exclusion criteria
Exclusion criteria: 1. Patients with a clear medical history or other significant diseases of the central nervous system, cardiovascular system, digestive system, urinary system, respiratory system, endocrine system, skeletal muscle system and other systems, which may interfere with the test results according to the investigators; 2. A history of risk factors for torsional ventricular tachycardia, short QT syndrome, long QT syndrome, or a family history of unexplained sudden death in youth (=400 mL within 3 months before screening; 13. Taking any drug that alters liver enzyme activity (especially CYP3A4, P-gp or Bcrp inhibitors or inducers such as itraconazole, ketoconazole, ritonavir, rifampicin, efavirenan, digoxin, etc.) for 28 days prior to screening; 14. Does not agree to avoid food or drink containing xanthine or caffeine or poppy seeds for 24 hours before and during the trial period, or does not agree to avoid vigorous exercise for 24 hours before the first administration and during the trial period, Or do not agree to avoid other foods (such as grapefruit or drinks containing grapefruit) that affect the absorption, distribution, metabolism, and excretion of the drug within 24 hours before the first dose and during the trial period; 15. Recent significant changes in eating or exercise habits; 16. A history of dysphagia or any gastrointestinal disorder that affects drug absorption; 17. Have any medical conditions that i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters of suldapyridine (WX-081) tablet and its metabolite M3; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event;Vital signs (blood pressure, pulse, respiration, body temperature);Physical examination;12 lead electrocardiogram (ECG);Laboratory tests (blood routine, blood biochemistry, coagulation routine, troponin T, urine routine); | — |
Countries
China
Contacts
Public ContactXiaojiao Li
The first hospital of Jilin University
Outcome results
None listed