NCT04176250

Early Bactericidal Activity of TBA-7371 in Pulmonary Tuberculosis

A Phase 2a, Dose Escalation, Controlled, Randomized Study to Evaluate Safety, Early Bactericidal Activity (EBA) and Pharmacokinetics of TBA-7371 in Adult Patients With Rifampicin-sensitive Pulmonary Tuberculosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Gates Medical Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-01-16
• Primary completion: 2022-10-05
• Completion: 2022-10-05
• First posted: 2019-11-25
• Last updated: 2024-04-11
• Results posted: 2024-04-11

Locations

4 sites across 1 country: South Africa