drugset / Trial / NCT02836483
A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK
RandomizedParallel-groupOpen-labelTreatment
Summary
A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.
Timeline
- Start
- 2016-12-10
- Primary completion
- 2019-07-01
- Completion
- 2019-07-01
Publications
- Lee SM, Choi SC, Mun KR, Seo JY, Cho YL, Shim TS, Lim HS. Pharmacokinetic and Pharmacodynamic Modeling Analysis of Delpazolid (LCB01-0371) in Adult Patients with Pulmonary Tuberculosis. J Clin Pharmacol. 2024 Jul;64(7):849-859. doi: 10.1002/jcph.2424. Epub 2024 Mar 4.
- Kim JS, Kim YH, Lee SH, Kim YH, Kim JW, Kang JY, Kim SK, Kim SJ, Kang YS, Kim TH, Mok J, Byun MK, Park HJ, Joh JS, Park YB, Lim HS, Choi H, Lee SH, Kim H, Yang J, Kim H, Shen X, Alsultan A, Cho I, Geiter L, Shim TS. Early Bactericidal Activity of Delpazolid (LCB01-0371) in Patients with Pulmonary Tuberculosis. Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0168421. doi: 10.1128/AAC.01684-21. Epub 2021 Dec 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Delpazolid | Small molecule | 400 mg | Oral |
| Subject | Delpazolid | Small molecule | 800 mg | Oral |
| Subject | Delpazolid | Small molecule | 1200 mg | Oral |
| Comparator | Ethambutol | Small molecule | — | Oral |
| Comparator | Isoniazid | Small molecule | — | Oral |
| Comparator | Linezolid | Other / unclassified | 600 mg | Oral |
| Comparator | Pyrazinamide | Small molecule | — | Oral |
| Comparator | Rifampicin | Small molecule | — | Oral |