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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03563599
• Other study ID #: Q203-TB-P2-ZA001
• Status: Completed
• Phase: Phase 2
• Start date: July 23, 2018
• Est. completion date: September 9, 2019

Study information

• Verified date: September 2019
• Source: Qurient Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 9, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
South Africa	TASK Applied Science	Cape Town
South Africa	UCT Lung Institute	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
Qurient Co., Ltd.

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The EBA (early bactericidal activity) of telacebec (Q203)	The EBA determined by the rate of change in the time to positivity (TTP) in sputum over the periods Days 0 to 14	Days 0 to 14 post dose