NCT03563599

A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)

An Open-label Randomized Study to Evaluate the Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203) in Treatment-naïve Patients With Newly Diagnosed Drug-sensitive Sputum Smear-positive Pulmonary Tuberculosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Qurient Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).

Conditions

• Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB

Interventions

Type	Name	Description
DRUG	Telacebec (Q203)	High, Mid, Low dose of telacebec
DRUG	Rifafour e-275	RHZE (R=rifampicin: H=isoniazid: Z=pyrazinamide: E=ethambutol)

Timeline

• Start date: 2018-07-23
• Primary completion: 2019-09-09
• Completion: 2019-09-09
• First posted: 2018-06-20
• Last updated: 2019-09-10

Locations

2 sites across 1 country: South Africa

Regulatory

• FDA-regulated drug study