tuberculosis
Conditions
Interventions
A group:Quabodepistat 30 mg QD, participates will take a single dose of study drug on Day 1 and will also take the study drug once daily from Day 9 to Day 15
B group:quabodepistat 90 mg QD,participates will take a single dose of study drug on Day 1 and will also take the study drug once daily from Day 9 to Day 15
Sponsors
Xuhui District Central Hospital, Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Chinese male or female participant between 18 and 55 years of age, inclusive. 2. Body mass index from 18.0 to 25.0 kg/m^2 (inclusive). 3. Body weight >= 50.0 kg. 4. In good health as judged by the investigator as determined by: (1) Medical history (2) Physical examination (3) Electrocardiogram (4) Serum chemistry, urinalysis, hematology, and serology tests. 5. Ability to provide written, informed consent prior to initiation of any trial-related procedures. 6. Ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
Exclusion criteria
Exclusion criteria: 1.Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigators or sponsor’s opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. This includes, but is not limited to, history of/or concurrent cardiac (or family history or sudden cardiac death or long QT syndrome), hepatic, renal, neurologic, psychiatric, endocrine, gastrointestinal, respiratory, hematologic (including significant bleeding or hemorrhagic tendencies), and immunologic disease or cholecystectomy. 2.Consumption of alcohol and/or food and beverages containing methylxanthines (including caffeine), grapefruit, grapefruit juice, pomelo, Seville oranges, or Seville orange juice within 72 hours prior to dosing. 3. History of drug and/or alcohol abuse (as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for moderate to severe alcohol/substance use disorder) within 2 years prior to screening. 4. History of or current hepatitis or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or HIV antibodies. 5. History of any significant drug allergy or known or suspected hypersensitivity, to any component of the IMP. 6. A positive urine or breath alcohol test and/or urine drug screen for substance of abuse at screening or upon admission to the trial site. 7. Participants having taken an investigational drug within 30 days prior to screening. 8. A history of difficulty in donating blood. 9. The donation of blood or plasma, or receipt of blood products within 30 days prior to the first dose of IMP. 10. Use of prescription or over-the-counter medications, traditional Chinese medicine and other herbal remedies or vitamin supplements (other than hormonal contraceptives [see Section 10.3]) within 14 days prior to the first dose of IMP and antibiotics within 30 days prior to the first dose of IMP. 11. Exposure to any substances known to stimulate hepatic microsomal enzymes within 30 days prior to screening through the end of the trial (eg, occupational exposure to pesticides, organic solvents, etc). 12. Use of tobacco products or daily exposure to second-hand smoke within 2 months prior to the screening visit, urine cotinine concentrations > 200 ng/mL or serum cotinine concentrations > 20 ng/mL at screening or check-in. 13. Participants presenting with, or having a history of, uncontrolled hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg) or symptomatic hypotension, or orthostatic hypotension which is defined as a decrease of = 30 mmHg in systolic blood pressure or a decrease of = 20 mmHg in diastolic blood pressure after at least 3 minutes standing compared with the previous supine blood pressure, OR development of symptoms. 14. Participants who have a supine pulse rate, after resting for at least 3 minutes, outside the range of 50 to 90 bpm. 15. Abnormal ECG findings at screening or check-in, as follows: (1)QTcF > 450 msec for male participants or > 470 msec for female participants (2) QRS interval > 120 msec (3)PR interval > 200 msec 16. History of unexplained syncope. 17. History of serious mental disorders, that, in the opinion of the investigator, would exclude the participant from participating in this trial. 18. Any participant who, in the opinion of the investigator, should not participate in the trial. 19. Pre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum (peak) plasma concentration of the drug;Time to maximum (peak) plasma concentration;The area under the concentration-time curve up to the last measurable concentration time (time t);The area under the concentration-time curve from time zero to infinity;Area under the concentration-time curve within the dosing interval;Apparent plasma clearance of the drug after extravascular administration;Terminal elimination half-life;Maximum (peak) plasma concentration/dose of the drug;Area under the concentration-time curve from time zero to the last measurable concentration (time t) / dose;Area under the concentration-time curve from time zero to infinity / dose;Area under the concentration-time curve during the dosing interval / dose; | — |
Countries
China
Contacts
Public ContactYun Liu
Xuhui District Central Hospital, Shanghai
Outcome results
None listed