Tuberculosis, Tuberculosis, Pulmonary
Conditions
Keywords
tuberculosis, TB, Sutezolid, pulmonary tuberculosis
Brief summary
This is a randomized, double-blind, placebo-controlled, single ascending dose study conducted at one study center in the United States. Four (4) cohorts of 8 subjects each (6 active and 2 placebo). Subjects will participate in only one cohort. Safety will be assessed throughout the study; serial ECGs and serial blood samples will be collected for the safety and PK assessment of sutezolid. Dose escalation to the next cohort (i.e., dose level) will not take place until the Sponsor, in conjunction with the Principal Investigator, has determined that adequate safety, tolerability and PK from the previous cohort has been demonstrated to permit proceeding to the next cohort. Interim PK analyses will be performed for the dose escalation decisions to reconsider the sampling time points as the study progresses. All samples will be sent for analysis and the bioanalytical lab will be unblinded and only run the analysis on active treatment subjects. Data from the analysis used for the escalation meetings will only include active treatment subjects, and will be blinded by subject. Subjects will be housed in the clinic from at least 24 hours prior (from Day -2), until 48 hours (Day 3) after dosing. Subjects will be contacted via a phone call for follow-up questioning about adverse events 7 days later (Study Day 10).
Interventions
DRUGSutezolid
Sutezolid supplied as tablets and matching placebo for oral administration.
DRUGPlacebo
Matching Sutezolid placebo
Sponsors
Global Alliance for TB Drug Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject understands study procedures and provides written, informed consent prior to all trial-related procedures. 2. Healthy adult male and females of non-childbearing potential, 19 to 50 years of age (inclusive) at the time of screening. 3. \< Body mass index (BMI) ≥ 18.5 and ≤ 32.0 (kg/m2) and a body weight of no less than 50.0 kg. 4. Medically healthy with no clinically significant, as determined by the Investigator, screening results (e.g., laboratory profiles are normal or up to Grade 1 per Division of Microbiology and Infectious Diseases \[DMID\] Toxicity Tables) medical history, vital signs, ECGs, physical examination findings. Laboratory results within the testing facility's normal range will not be considered AEs when referenced to the DMID assessment/grading scale. If exclusionary laboratory criteria are met, values may be confirmed by repeat evaluation. 5. No use of tobacco or nicotine containing products (including smoking cessation products), for a minimum of 6 months prior to dosing. 6. Females of non-childbearing potential, having undergone one of the following sterilization procedures at least 6 months prior to dosing: 1. Hysteroscopic sterilization 2. Bilateral tubal ligation or bilateral salpingectomy 3. Hysterectomy 4. Bilateral oophorectomy 5. or be postmenopausal with amenorrhea for at least 1 year prior to the first dose with serum follicle stimulating hormone (FSH) levels consistent with postmenopausal status at screening. 7. Non-vasectomized males (or males vasectomized less than 120 days prior to study start), must agree to the following during study participation and for 90 days following the last administration of study drug: 1. use a condom with spermicide while engaging in sexual activity or be sexually abstinent 2. not donate sperm during this time. In the event the sexual partner is surgically sterile, use of a condom with spermicide is not necessary. None of the restrictions listed above are required for vasectomized males whose procedure was performed more than 120 days prior to study start. In the event the sexual partner is surgically sterile, use of a condom with spermicide is not necessary. None of the restrictions listed above are required for vasectomized males whose procedure was performed more than 120 days prior to study start. 8. Willing to answer inclusion and
Exclusion criteria
questionnaire at check-in. 9. Be able to comply with the protocol and the assessments therein, including all restrictions. 10. Is willing and able to remain in the study unit for the entire duration of the assigned confinement period and receive a phone call for follow-up questioning about AEs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of single oral doses of sutezolid in healthy adult subjects evaluated by Treatment Emergent Adverse Events (TEAEs) | Days 0-10 | Safety will be evaluated by Treatment Emergent Adverse Events (TEAEs) following doses of sutezolid or placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of single oral doses of sutezolid using Cmax | Days 0-10 | This will be measured through PK parameters like Cmax; Cmax = maximum observed concentration |
| Pharmacokinetics (PK) of single oral doses of sutezolid using AUC | Days 0-10 | This will be measured through PK parameters like AUC; AUC = Area under the curve, |
| Pharmacokinetics (PK) of single oral doses of sutezolid using Tmax | Days 0-10 | This will be measured through PK parameters like Tmax; Tmax = Time of the maximum drug concentration (obtained without interpolation) |
Countries
United States
Outcome results
None listed