PanACEA Sutezolid Dose-finding and Combination Evaluation
Summary
This study is an open-label, randomized, controlled, multi-center Phase IIB dose-finding trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response-relationship of different doses of sutezolid (STZ) in combination with bedaquiline, delamanid and moxifloxacin in adults with newly diagnosed, uncomplicated, smear positive and drug sensitive pulmonary tuberculosis. Participants will be randomized to one of five arms containing bedaquiline, delamanid and moxifloxacin with different doses of STZ (0mg, 600mg once daily (OD), 1200mg OD, 600 mg twice daily (BD), 800 mg BD). Study treatment duration will be three months, followed by a follow-up period of 2 weeks. The primary objective is to identify the optimal dose of sutezolid to be used in subsequent studies that provides the best efficacy at acceptable safety of the drug by describing the safety, tolerability and exposure toxicity relationship of sutezolid (and its main metabolite) given over three months, in combination with standard-dose bedaquiline, delamanid and moxifloxacin, compared to standard-dose bedaquiline, delamanid and moxifloxacin alone.
Timeline
- Start
- 2021-05-06
- Primary completion
- 2022-09-30
- Completion
- 2022-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midazolam | Small molecule | 2 mg | Oral |
| Subject | Sutezolid | Small molecule | 600 mg | Oral |
| Subject | Sutezolid | Small molecule | 800 mg | Oral |
| Subject | Sutezolid | Small molecule | 1200 mg | Oral |
| Background | Bedaquiline | Small molecule | 200 mg | Oral |
| Background | Delamanid | Small molecule | 100 mg | Oral |
| Background | Moxifloxacin | Small molecule | 400 mg | Oral |