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Early Bactericidal Activity of TBA-7371 in Pulmonary Tuberculosis

NCT04176250 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2024-04-11

Study results available
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Summary

The purpose of this study is to assess the safety, early bactericidal activity (EBA) and pharmacokinetics of TBA-7371 in adult participants with rifampicin-sensitive tuberculosis and select dose regimen(s) for future studies.

Conditions

  • Pulmonary Tuberculosis

Interventions

DRUG

TBA-7371

Participants will receive TBA-7371 oral suspension 100 milligram (mg) once daily (QD) for 14 days.

DRUG

TBA-7371

Participants will receive TBA-7371 oral suspension 100 mg twice daily (BID) for 14 days.

DRUG

TBA-7371

Participants will receive TBA-7371 oral suspension 200 mg QD for 14 days.

DRUG

TBA-7371

Participants will receive TBA-7371 oral suspension 100 mg three times daily (TID) for 14 days.

DRUG

TBA-7371

Participants will receive TBA-7371 oral suspension 400 mg QD for 14 days.

DRUG

HRZE

Participants will receive Isoniazid \[H\] / rifampicin \[R\] / pyrazinamide \[Z\] / ethambutol \[E\] (HRZE), a fixed dose combination tablet QD for 14 days, based on weight as 40-54 kilograms (kg): 3 tablets; 55-70 kg: 4 tablets and 71 kg and over: 5 tablets.

Sponsors & Collaborators

  • Gates Medical Research Institute

    lead OTHER

Principal Investigators

  • Gates MRI · Gates Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2022-10-05
Completion
2022-10-05

Countries

  • South Africa

Study Locations

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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 NCT04176250 on ClinicalTrials.gov