Tuberculosis
Conditions
Interventions
Sorfequiline 200 mg
Sorfequiline 100 mg
Sponsors
TB Alliance
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to undertaking any trial-related procedures. 2. Participants aged 18 to 65 years, inclusive. 3. Body weight (in light clothing and no shoes) =35 kg. 4. Sputum positive for tubercle bacilli (at least 1+ on the IUATLD/WHO scale on smear microscopy) at the trial laboratory. 5. DS-TB participants defined as the following: a. Sensitive to rifampicin and isoniazid by rapid sputum-based test (see trial Mycobacteriology Laboratory Manual) AND b. Either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB. 6. A chest x-ray during the screening period or within 14 days of screening which in the opinion of the investigator is compatible with pulmonary TB. 7. Be of non-childbearing potential OR using effective methods of birth control as defined below: NON-CHILDBEARING POTENTIAL a. Participant is not heterosexually active or practices sexual abstinence O b. Female participant or male participant’s female sexual partner: bilateral oophorectomy, bilateral tubal ligation, and/or hysterectomy or has been postmenopausal with a history of no menses for at least 12 consecutive months OR c. Male participant or female participant’s male sexual partner: vasectomized or has had a bilateral orchidectomy at least 3 months prior to screening Effective method of birth control is defined as 1 of the following: a. Double-barrier method which can include a combination of male condom, diaphragm, cervical cap, or female condom. Note: Female and male condom should not be used together. b. Combination of a barrier method with hormone-based contraceptives or an intra-uterine device. Both male and female participants must be willing to continue practicing birth control methods and not be planning to conceive throughout treatment and for 6 months after the last dose of IMP.
Exclusion criteria
Exclusion criteria: 1. History or presence of pulmonary, hepatic, musculoskeletal abnormalities, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, psychiatric disease, or any condition as determined by the investigator that could impact the participant’s ability to participate in the trial. 2. Cardiovascular abnormalities such as pathological heart murmur, acute or chronic cardiac diseases including but not limited to angina (stable or unstable), acute coronary syndrome in the last 6 months, and any type of cardiomyopathy. 3. Karnofsky performance status score of <60%. 4. Abuse of alcohol or illegal drugs that in the opinion of the investigator would compromise the participant’s safety or ability to follow through with all protocol specified restrictions, visits, and evaluations. 5. Historical and/or current use of local traditional medications/herbs (such as St. John’s wort) which in the opinion of the investigator would compromise the participant’s safety or ability to follow through with all protocol-specified restrictions, visits, and evaluations. 6. Being, or about to be, treated for malaria. 7. Is critically ill and, in the judgment of the investigator, has a diagnosis likely to result in death during the trial or the follow-up period. 8. Any evidence of extrapulmonary TB. Pleural effusion occupying <50% of hemithorax or concomitant intra- or extra-thoracic lymphadenopathy are not exclusions. 9. For participants living with HIV only: a. CD4+ count<200 cells/µL. b. WHO Clinical Stage 4 HIV disease c. Participants who do not agree to use DTG/TFV/3TC if ARV therapy is indicated, whilst participating in the trial d. If initiation of ARV therapy is indicated within the treatment Period, participants who are known to be intolerant, non-responsive to DTG/TFV/3TC or have DTG/TFV/3TC as a contraindication. 10. Having participated in other clinical trials with investigational agents within 8 weeks prior to Day 1 or currently randomised in an investigational drug trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of TEAEs, by severity, drug relatedness, seriousness, leading to early discontinuation, and leading to death; and ECG, vital signs, and quantitative and qualitative clinical laboratory result measurements, changes in ophthalmic exam for visual acuity and changes noted in peripheral neuropathy, including observed and changes from baseline; by 17 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to stable sputum culture conversion to negative status using data from visit cultures, time course of TTP, proportion of participants with a favourable outcome and, treatment failure/relapse at 26 weeks and 52 weeks after the end of treatment (EOT). | — |
Countries
South Africa
Contacts
Public ContactMorounfolu Olugbosi
Study Physician
Outcome results
None listed