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

Outcome

Missed primary endpoint

registry Stage 1: 3 mg OPC-167832 vs Stage 1: RHEZ; EBA Ratio 0.605 (95% CI 0.338 to 0.871) NCT03678688 ↗

Publications

Dawson R, Diacon AH, De Jager V, Narunsky K, Moodley VM, Stinson KW, Liu Y, Zheng B, Hafkin J. Safety, pharmacokinetics, and early bactericidal activity of quabodepistat in combination with delamanid, bedaquiline, or both in adults with pulmonary tuberculosis: a randomised, active-controlled, open-label trial. Lancet Infect Dis. 2025 Apr;25(4):435-444. doi: 10.1016/S1473-3099(24)00601-7. Epub 2024 Nov 26.

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	Rifampicin	Small molecule	300 mg	Oral
Comparator	Rifampicin	Small molecule	450 mg	Oral
Comparator	Rifampicin	Small molecule	600 mg	Oral
Comparator	Rifampicin	Small molecule	750 mg	Oral