drugset / Trial / NCT03678688
A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis
Phase 1/2
Completed
122 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
Bill and Melinda Gates Foundation · collab
RandomizedSequentialOpen-labelTreatment
Summary
This trial will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of multiple oral doses of OPC-167832 in participants with uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis (TB).
Timeline
- Start
- 2018-10-18
- Primary completion
- 2022-02-14
- Completion
- 2022-03-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 400 mg | Oral |
| Subject | Delamanid | Small molecule | 300 mg | Oral |
| Comparator | Ethambutol | Small molecule | 550 mg | Oral |
| Comparator | Ethambutol | Small molecule | 825 mg | Oral |
| Comparator | Ethambutol | Small molecule | 1100 mg | Oral |
| Comparator | Ethambutol | Small molecule | 1375 mg | Oral |
| Comparator | Isoniazid | Small molecule | 150 mg | Oral |
| Comparator | Isoniazid | Small molecule | 225 mg | Oral |
| Comparator | Isoniazid | Small molecule | 300 mg | Oral |
| Comparator | Isoniazid | Small molecule | 375 mg | Oral |
| Comparator | Pyrazinamide | Small molecule | 800 mg | Oral |
| Comparator | Pyrazinamide | Small molecule | 1200 mg | Oral |
| Comparator | Pyrazinamide | Small molecule | 1600 mg | Oral |
| Comparator | Pyrazinamide | Small molecule | 2000 mg | Oral |
| Subject | Quabodepistat | Small molecule | 3 mg | Oral |
| Subject | Quabodepistat | Small molecule | 10 mg | Oral |
| Subject | Quabodepistat | Small molecule | 30 mg | Oral |
| Subject | Quabodepistat | Small molecule | 90 mg | Oral |
| Comparator | Rifampin | Small molecule | 300 mg | Oral |
| Comparator | Rifampin | Small molecule | 450 mg | Oral |
| Comparator | Rifampin | Small molecule | 600 mg | Oral |
| Comparator | Rifampin | Small molecule | 750 mg | Oral |