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

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).

Study Overview

• Status: Completed
• Conditions: Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB
• Intervention / Treatment: Drug: Telacebec (Q203); Drug: Rifafour e-275

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • UCT Lung institute
  • Cape Town, South Africa
    • TASK Applied Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telacebec (Q203) tablet	Drug: Telacebec (Q203); High, Mid, Low dose of telacebec
Active Comparator: Rifafour e-275	Drug: Rifafour e-275; RHZE (R=rifampicin: H=isoniazid: Z=pyrazinamide: E=ethambutol)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Qurient Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2018
• Primary Completion (Actual): September 9, 2019
• Study Completion (Actual): September 9, 2019

Study Registration Dates

• First Submitted: June 9, 2018
• First Submitted That Met QC Criteria: June 9, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: Q203-TB-P2-ZA001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No