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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03563599
Recruitment Status : Active, not recruiting
First Posted : June 20, 2018
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Qurient Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB Drug: Telacebec (Q203) Drug: Rifafour e-275 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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)




Primary Outcome Measures :
  1. The EBA (early bactericidal activity) of telacebec (Q203) [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563599


Locations
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South Africa
TASK Applied Science
Cape Town, South Africa
UCT Lung Institute
Cape Town, South Africa
Sponsors and Collaborators
Qurient Co., Ltd.

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Responsible Party: Qurient Co., Ltd.
ClinicalTrials.gov Identifier: NCT03563599     History of Changes
Other Study ID Numbers: Q203-TB-P2-ZA001
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypersensitivity
Tuberculosis, Pulmonary
Immune System Diseases
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections