drugset / Trial / NCT03563599
A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).
Timeline
- Start
- 2018-07-23
- Primary completion
- 2019-09-09
- Completion
- 2019-09-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ethambutol | Small molecule | — | — |
| Comparator | Isoniazid | Small molecule | — | — |
| Comparator | Pyrazinamide | Small molecule | — | — |
| Comparator | Rifampicin | Small molecule | — | — |
| Subject | Telacebec | Small molecule | 100 mg | Oral |
| Subject | Telacebec | Small molecule | 200 mg | Oral |
| Subject | Telacebec | Small molecule | 300 mg | Oral |