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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 : Completed
First Posted : June 20, 2018
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Qurient Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 9, 2018
First Posted Date  ICMJE June 20, 2018
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE July 23, 2018
Actual Primary Completion Date September 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB
Intervention  ICMJE
  • Drug: Telacebec (Q203)
    High, Mid, Low dose of telacebec
  • Drug: Rifafour e-275
    RHZE (R=rifampicin: H=isoniazid: Z=pyrazinamide: E=ethambutol)
Study Arms  ICMJE
  • Experimental: Telacebec (Q203) tablet
    Intervention: Drug: Telacebec (Q203)
  • Active Comparator: Rifafour e-275
    Intervention: Drug: Rifafour e-275
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 9, 2019
Actual Primary Completion Date September 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03563599
Other Study ID Numbers  ICMJE Q203-TB-P2-ZA001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qurient Co., Ltd.
Study Sponsor  ICMJE Qurient Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Qurient Co., Ltd.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP