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

NCT03563599 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-09-10

No results posted yet for this study

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).

Conditions

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

Interventions

DRUG

Telacebec (Q203)

High, Mid, Low dose of telacebec

DRUG

Rifafour e-275

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

Sponsors & Collaborators

  • Qurient Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-23
Primary Completion
2019-09-09
Completion
2019-09-09
FDA Drug
Yes

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03563599 on ClinicalTrials.gov