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A Phase 2 Trial to Evaluate the EBA, Safety and Tolerability of Eto Alone and in Combination With BVL-GSK098

NCT05473195 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-08-21

No results posted yet for this study

Summary

To evaluate the 7-day early bactericidal activity (EBA), pharmacokinetics (PK), safety and tolerability of ethionamide (Eto) with or without BVL-GSK098 in participants with rifampicin- and isoniazid-susceptible pulmonary TB.

Conditions

  • Rifampicin- and Isoniazid-Susceptible Pulmonary Tuberculosis (TB)

Interventions

DRUG

BVL-GSK098 9mg

BVL-GSK098 9 mg once daily po OD plus ethionamide 250 mg po OD (b9Eto250) BVL-GSK098 27 mg OD plus ethionamide 125 mg po OD (b27Eto125 BVL-GSK098 27 mg OD plus ethionamide 250 mg po OD (b27Eto250) BVL-GSK098 27 mg OD plus ethionamide 500 mg po OD (b27Eto500)

DRUG

Ethionamide 250mg

Ethionamide 250 mg po OD (Eto250)

DRUG

Ethionamide 250 mg

Ethionamide 750 mg po given in a single or divided dose (Eto750)

DRUG

Isoniazid 300 MG

Isoniazid 300 mg po OD (INH)

Sponsors & Collaborators

Principal Investigators

  • Reinard McPherson, MBChB · TASK

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
2022-12-06
Primary Completion
2024-04-16
Completion
2024-04-16

Countries

  • South Africa

Study Locations

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Entities

Companies

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 NCT05473195 on ClinicalTrials.gov