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Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB

NCT05221502 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-05-26

No results posted yet for this study

Summary

This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid, ethambutol, pyrazinamide (RHEZ) administered for 26 weeks.

Conditions

  • Pulmonary TB

Interventions

DRUG

Delamanid

Delamanid (300 mg QD) for 17 weeks

DRUG

Bedaquiline

Bedaquiline (400 mg QD x 2 weeks, then 200 mg TIW) for 17 weeks

DRUG

OPC-167832

OPC-167832 at a dose of either 10 mg, 30 mg, or 90 mg for 17 weeks

DRUG

RHEZ

RHEZ (RIFAFOUR single dose combination tablets) for 8 weeks

DRUG

Rifampin

Rifampin tablets for 18 weeks

DRUG

Isoniazid

Isoniazid tablets for 18 weeks

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-12
Primary Completion
2024-04-08
Completion
2024-05-19
FDA Drug
Yes

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05221502 on ClinicalTrials.gov