drugset / Trial / NCT02365623
An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to explore safety and efficacy of TMC207 administered as part of a multi-drug regimen for 24 to 48-week treatment in Japanese participants with pulmonary multi-drug resistant tuberculosis (MDR-TB), and to evaluate pharmacokinetics (PK) of TMC207 and its primary metabolite M2.
Timeline
- Start
- 2015-02-18
- Primary completion
- 2018-11-08
- Completion
- 2018-11-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 200 mg | — |
| Background | Amikacin | Small molecule | — | — |
| Background | Amoxicillin-clavulanate | Other / unclassified | — | — |
| Background | Clofazimine | Small molecule | — | — |
| Background | Cycloserine | Small molecule | — | — |
| Background | Ethambutol | Small molecule | — | — |
| Background | Ethionamide | Small molecule | — | — |
| Background | Kanamycin | Small molecule | — | — |
| Background | Levofloxacin | Small molecule | — | — |
| Background | Linezolid | Other / unclassified | — | — |
| Background | Pyrazinamide | Small molecule | — | — |
| Background | enviomycin | Protein / enzyme biologic | — | — |
| Background | para-aminosalicylic acid | Unknown | — | — |
| Background | streptomycin | Other / unclassified | — | — |