drugset / Trial / NCT05382312
Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis
RandomizedParallel-groupSingle-blindOther
Summary
This study measured the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of GSK3036656 in combination with either delamanid, bedaquiline or BTZ-043 and delamanid in combination with bedaquiline or standard of care, for 14 days, in participants with newly diagnosed sputum smear positive drug-sensitive pulmonary tuberculosis. Participants reverted to the standard treatment (RIFAFOUR e-275) once the study treatment (Day 1 to Day 14) was completed.
Timeline
- Start
- 2022-07-26
- Primary completion
- 2025-05-27
- Completion
- 2025-05-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BTZ-043 | Small molecule | 1000 mg | — |
| Subject | Bedaquiline | Small molecule | 400 mg | — |
| Subject | Delamanid | Small molecule | 300 mg | — |
| Subject | Ganfeborole | Small molecule | 20 mg | Oral |
| Subject | Linezolid | Other / unclassified | 600 mg | — |
| Subject | Moxifloxacin | Small molecule | 400 mg | — |
| Subject | Pretomanid | Small molecule | 200 mg | — |
| Subject | Rifafour e-275 | Unknown | — | — |