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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-23

Study Completion Date

2019-09-09

Brief Summary

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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).

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telacebec (Q203) tablet

Group Type EXPERIMENTAL

Telacebec (Q203)

Intervention Type DRUG

High, Mid, Low dose of telacebec

Rifafour e-275

Group Type ACTIVE_COMPARATOR

Rifafour e-275

Intervention Type DRUG

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

Interventions

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Telacebec (Q203)

High, Mid, Low dose of telacebec

Intervention Type DRUG

Rifafour e-275

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No