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

 1. A new episode of pulmonary TB determined by testing at the study appointed laboratory:
 Mycobacterium tuberculosis positive and rifampicin and isoniazid sensitive on a rapid
 molecular test

 2. A chest X-ray taken no more than 14 days before Screening which in the opinion of the
 Investigator is consistent with TB

 3. Sputum smear positive on direct microscopy for acid-fast bacilli on at least 1
 pre-treatment sputum sample

 4. Ability to produce an adequate volume of sputum as determined by an approximately
 16-hour overnight sample collection

 5. Be of non-childbearing potential or using effective methods of birth control, as
 defined in the protocol

 Exclusion Criteria:

 1. The patient is mentally or legally incapacitated at Screening

 2. Any condition or circumstance, in the opinion of the Investigator, which may make the
 patient unlikely to complete the study or comply with study procedures and
 requirements, or may pose a risk to the patient's safety

 3. Clinically significant evidence of extra-thoracic TB (miliary TB, abdominal TB,
 urogenital TB, osteoarthritic TB, TB meningitis), as judged by the Investigator

 4. The patient has been infected with hepatitis B or C virus as confirmed by tests for
 hepatitis B core antibodies, hepatitis B surface antigens, and the hepatitis C virus
 antibodies

 5. The patient with history of allergic reaction to isoniazid, rifampicin, pyrazinamide,
 ethambutol or related substances (eg, tosylate), as confirmed by the clinical
 judgement of the Investigator