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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03563599

Enrollment

Registered

2018-06-20

Start date

2018-07-23

Completion date

2019-09-09

Last updated

2019-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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).

Interventions

DRUGTelacebec (Q203)

High, Mid, Low dose of telacebec

DRUGRifafour e-275

RHZE (R=rifampicin: H=isoniazid: Z=pyrazinamide: E=ethambutol)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The EBA (early bactericidal activity) of telacebec (Q203)	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

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026