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A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK

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ClinicalTrials.gov Identifier: NCT02836483
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
LegoChem Biosciences, Inc

Study Description
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Brief Summary:
A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.

Condition or disease Intervention/treatment Phase
Pulmonary Tuberculosis Drug: LCB01-0371 800mg, QD Drug: LCB01-0371 400mg, BID Drug: LCB01-0371 800mg, BID Drug: Tubes 3~5Tablet, QD Drug: Zyvox 600mg, BID Phase 2

Detailed Description:
This study is designed to explore antituberculosis of LCB01-0371 through the assess of the early bactericidal activity, safety of administration.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial to Evaluate the EBA, Safety and PK of Orally Administered LCB01-0371 in Adult Patients With Smear-positive Pulmonary Tuberculosis
Actual Study Start Date : December 10, 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
LCB01-0371 800mg, QD
 Drug: LCB01-0371 800mg, QD
Oral administration
Other Name: LCB01-0371
Experimental: Group 2
LCB01-0371 400mg, BID
 Drug: LCB01-0371 400mg, BID
Oral administration
Other Name: LCB01-0371
Experimental: Group 3
LCB01-0371 800mg, BID
 Drug: LCB01-0371 800mg, BID
Oral administration
Other Name: LCB01-0371
Active Comparator: Group 4
Tubes 3~5Tablet, QD
 Drug: Tubes 3~5Tablet, QD
Oral administration
Other Name: Tubes Tablet
Active Comparator: Group 5
Zyvox 600mg, BID
 Drug: Zyvox 600mg, BID
Oral administration
Other Name: Zyvox Tablet


Outcome Measures
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Primary Outcome Measures :
  1. EBA0-14 [ Time Frame: V2(Baseline, Day 1), V9(Day 15) ]
    The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from baseline at Day 15


Secondary Outcome Measures :
  1. EBA0-2 [ Time Frame: V2(Baseline, Day 1), V4(Day 3) ]
    The standard early bactericidal activity (standard EBA) expressed as the change of log colony forming units of sputum from baseline at Day 3

  2. EBA2-14 [ Time Frame: V4(Day 3), V9(Day 15) ]
    The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 3 at Day 15

  3. EBA2-7 [ Time Frame: V4(Day 3), V6(Day 8) ]
    The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 2 at Day 8


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Korean who After listening to understand the details about the clinical trial, decided to join in the clinical study, and written consent
  2. The age of consent at the time of writing, only men and women under 70 years old over 19 years old
  3. The First diagnosis of tuberculosis and have not received tuberculosis treatment for TB patients

Exclusion Criteria:

  1. Known history of Rifampicin or Isoniazid resistance
  2. Serious TB for example tuberculous encephalomeningitis, It is impossible to participate in clinical trials
  3. Known History of nontuberculous mycobacteria positive
  4. Other pulmonary disease which is impossible to participate in clinical trial except TB
Contacts and Locations
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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): NCT02836483


Contacts
Contact: T.S. Sim, M.D., Ph.D 82-2-3010-3892 shimts@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: T.S. Sim, M.D., Ph.D    82-2-3010-3892    shimts@amc.seoul.kr   
Sponsors and Collaborators
LegoChem Biosciences, Inc
Investigators
Principal Investigator: T.S Sim, M.D., Ph.D Asan Medical Center
More Information
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Responsible Party: LegoChem Biosciences, Inc
ClinicalTrials.gov Identifier: NCT02836483     History of Changes
Other Study ID Numbers: LCB01-0371-15-2-01
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
 Respiratory Tract Infections
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action