Drug-resistant tuberculosis
Conditions
Interventions
Test group-single dose(SAD):20mg QD orally (3 cases)
50mg QD orally (8 cases)
100mg QD orally (8 cases)
200mg QD orally (8 cases)
300mg QD orally (8 cases)
400mg QD orally (8 cases)
Blank control group-single dose(SAD):20mg QD orally (1 case)
50mg QD orally (2 cases)
100mg QD orally (2 cases)
200mg QD orally (2 cases)
300mg QD orally (2 cases)
400mg QD orally (2 cases)
Blank control group-single dose:20mg QD oral
Experimental group-food influence:Group A: 1. Take 100 mg QD once on an empty stomach in the first cycle, take 100 mg QD once after a meal in the second cycle
take 100 mg QD once after a meal in the first cycle, and take 100 mg QD once on an empty stomach in the second cycle
Test group-multiple doses (MAD):100mg QD orally for 14 days (8 cases)
200mg QD orally for 14 days (8 cases)
400mg QD orally for 14 days (8 cases)
Blank control group-multiple doses (MAD):100mg QD was taken orally for 14 days (2 cases)
200mg QD was taken orally for 14 days (2 cases)
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Selection criteria for blank sample collection test: You can be selected for this test only if you meet all the following selection criteria: 1. Healthy adult male or female subjects aged between 18 and 45 (including the threshold, subject to the time of signing the informed consent form); 2. The body mass index is 18~24 kg/m2 (including the critical value), the weight of male subjects shall not be less than 50 kg, and the weight of female subjects shall not be less than 45 kg; 3. The subjects had no abnormalities or abnormalities in the physical examination, vital signs, laboratory examinations, and 12-lead electrocardiogram during the screening period. The QTcF of female subjects was <= 470 ms and the QTcF of male subjects was <= 450 ms (corrected by Fridericia's formula); 4. The subject fully understands the purpose, nature, methods and possible adverse reactions of the trial, volunteers to be a subject, and signs an informed consent form; 5. Willing to complete the test in accordance with the requirements of the plan. SAD, food effects, and MAD test selection criteria: All the following selection criteria can be selected for this test: 1. Healthy adult male or female subjects aged between 18 and 45 (including the threshold, subject to the time of signing the informed consent form); 2. The body mass index is 18~24 kg/m2 (including the critical value), the weight of male subjects shall not be less than 50 kg, and the weight of female subjects shall not be less than 45 kg; 3. The subjects had no abnormalities or abnormalities in the physical examination, vital signs, laboratory examinations, 12-lead electrocardiogram, lateral chest X-ray, and abdominal B-ultrasound (liver, gallbladder, pancreas, spleen and kidney) during the screening period. The QTcF of the test subjects is <= 470 ms, and the QTcF of the male subjects is <= 450 ms (corrected by Fridericia's formula); 4. Agree to take effective contraceptive measures during the trial period and within 6 months after the last dose; see Appendix 1 for specific contraceptive measures; 5. The subject fully understands the purpose, nature, methods and possible adverse reactions of the trial, volunteers to be a subject, and signs an informed consent form; 6. Willing to complete the experiment in accordance with the requirements of the plan.
Exclusion criteria
Exclusion criteria: Exclusion criteria for blank sample collection test: Any one of the following exclusion criteria will be excluded: 1. People with a history of drug or food allergies, known or suspected to be allergic to materials or any of them (such as disinfectants, iodophors, etc. that may be used in the blood collection process) that may be used in clinical trials; 2. Diseases and factors with abnormal clinical manifestations that need to be excluded, including but not limited to cardiovascular, liver, lung, kidney disease or other acute or chronic gastrointestinal diseases, respiratory diseases, musculoskeletal diseases, as well as blood, endocrine, nerve, and Mental and other systemic diseases, or any other diseases or physiological conditions that can interfere with the test results; 3. Those who have suffered from a major clinically significant disease or have undergone major surgical operations and received blood or blood component transfusions within 3 months before the administration, or those who are expected to undergo major surgery during the trial period; 4. Those who have a history of arrhythmia with accompanying symptoms or a history of bradycardia; 5. Those with serum albumin < 3.4 g/dL; 6. Those who have difficulty in venous blood collection; 7. Those who have had a history of drug abuse within 2 years before the screening period or used drugs in the 3 months before the trial, or tested positive for drug abuse during the screening period and/or admission period; 8. Those who smoked more than 5 cigarettes per day in the 3 months before screening, or who could not control smoking during the test or habitually used nicotine-containing products; 9. Drinking more than 14 units of alcohol per week in the 6 months before screening (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcoholic spirits or 150 mL of wine) or unable to control drinking during hospitalization or 48 before administration h People who have taken alcohol-containing products, or have a positive alcohol breath test during the screening period and/or admission period; 10. Any prescription drugs (including drugs that induce and inhibit liver drug enzymes), over-the-counter drugs or Chinese herbal medicines have been used within 14 days before the start of the trial; any vaccines have been vaccinated in the last 28 days, and any biological agents have been received in the 4 months before selection (Antibody or its derivative); 11. Those who have taken food or beverages (such as grapefruit, etc.) that can induce or inhibit liver metabolic enzymes within 14 days before the start of the trial; 12. One or more tests of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or Treponema pallidum antibody test are positive; 13. Women who have a positive pregnancy test during screening or admission or are breastfeeding; 14. Received any other study drug administration within 3 months before screening; 15. Those who have a history of blood donation or have lost more than 400 mL of blood or plan to donate blood within 3 months before screening; 16. Any other situation that the investigator believes may affect the subjects informed consent or follow the trial protocol, or the subjects participation in the trial may affect the trial results or their own safety. SAD, food effects, and MAD test exclusion criteria: Any one of the following exclusion criteria will be excluded: 1. Have any clear history of drug allergy, especially for ingredients similar to t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of AE; the incidence of SAE and unexpected serious adverse events; laboratory examinations; ECG; vital signs; physical examinations; eye examinations and depression scale scores.;Single-dose PK parameters: peak time (Tmax), peak concentration (Cmax), elimination half-life (t1/2), area under the plasma concentration-time curve from the first dose to 12 hours (AUC0-12); | — |
Countries
China
Contacts
Public ContactMiao Jia
West China Hospital of Sichuan University
Outcome results
None listed