Trial

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

Study Director
Start Date
7 / 2018
Trial Phase
Phase II
Trial Status
published
Current Enrollment
61 Sept 9 2019
Target Enrollment
60
Overview

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).  Posted to clinicaltrials.gov June 21, 2018  NCT03563599  As of March 19, 2019, enrollment complete.

Primary Outcome Measures :

  1. The EBA (early bactericidal activity) of telacebec (Q203) [ Time Frame: Days 0 to 14 post dose ]

    The EBA determined by the rate of change in the time to positivity (TTP) in sputum over the periods Days 0 to 14

  2. Comparator Rifafour e-275

Related Links
de Jager, Veronique R et al. “Telacebec (Q203), a New Antituberculosis Agent.” The New England Journal of Medicine vol. 382,13 (2020): 1280-1281.
Registry Link
Developer Associations
Qurient Co., Ltd
Compound Associations
Telacebec (Q203)