NCT02836483

Brief Summary

A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

December 10, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

2.6 years

First QC Date

July 5, 2016

Last Update Submit

February 4, 2020

Conditions

Pulmonary Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • EBA0-14

    The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from baseline at Day 15

    V2(Baseline, Day 1), V9(Day 15)

Secondary Outcomes (3)

  • EBA0-2

    V2(Baseline, Day 1), V4(Day 3)

  • EBA2-14

    V4(Day 3), V9(Day 15)

  • EBA2-7

    V4(Day 3), V6(Day 8)

Study Arms (6)

Group 1

EXPERIMENTAL

LCB01-0371 800mg, QD

Drug: LCB01-0371 800mg, QD

Group 2

EXPERIMENTAL

LCB01-0371 400mg, BID

Drug: LCB01-0371 400mg, BID

Group 3

EXPERIMENTAL

LCB01-0371 800mg, BID

Drug: LCB01-0371 800mg, BID

Group 4

ACTIVE COMPARATOR

Tubes 3\~5Tablet, QD

Drug: Tubes 3~5Tablet, QD

Group 5

ACTIVE COMPARATOR

Zyvox 600mg, BID

Drug: Zyvox 600mg, BID

Group 6

EXPERIMENTAL

LCB01-0371 1200mg, QD

Drug: LCB01-0371 1200mg, QD

Interventions

LCB01-0371 800mg, QDDRUG

Oral administration

Also known as: LCB01-0371
Group 1
LCB01-0371 400mg, BIDDRUG

Oral administration

Also known as: LCB01-0371
Group 2
LCB01-0371 800mg, BIDDRUG

Oral administration

Also known as: LCB01-0371
Group 3
Tubes 3~5Tablet, QDDRUG

Oral administration

Also known as: Tubes Tablet
Group 4
Zyvox 600mg, BIDDRUG

Oral administration

Also known as: Zyvox Tablet
Group 5
LCB01-0371 1200mg, QDDRUG

Oral administration

Also known as: LCB01-0371
Group 6

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Korean who After listening to understand the details about the clinical trial, decided to join in the clinical study, and written consent
  • The age of consent at the time of writing, only men and women under 75 years old over 19 years old
  • The First diagnosis of tuberculosis and have not received tuberculosis treatment for TB patients

You may not qualify if:

  • Known history of Rifampicin or Isoniazid resistance
  • Serious TB for example tuberculous encephalomeningitis, It is impossible to participate in clinical trials
  • Known History of nontuberculous mycobacteria positive
  • Other pulmonary disease which is impossible to participate in clinical trial except TB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (2)

  • Lee SM, Choi SC, Mun KR, Seo JY, Cho YL, Shim TS, Lim HS. Pharmacokinetic and Pharmacodynamic Modeling Analysis of Delpazolid (LCB01-0371) in Adult Patients with Pulmonary Tuberculosis. J Clin Pharmacol. 2024 Jul;64(7):849-859. doi: 10.1002/jcph.2424. Epub 2024 Mar 4.

    PMID: 38436463DERIVED

  • Kim JS, Kim YH, Lee SH, Kim YH, Kim JW, Kang JY, Kim SK, Kim SJ, Kang YS, Kim TH, Mok J, Byun MK, Park HJ, Joh JS, Park YB, Lim HS, Choi H, Lee SH, Kim H, Yang J, Kim H, Shen X, Alsultan A, Cho I, Geiter L, Shim TS. Early Bactericidal Activity of Delpazolid (LCB01-0371) in Patients with Pulmonary Tuberculosis. Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0168421. doi: 10.1128/AAC.01684-21. Epub 2021 Dec 6.

    PMID: 34871098DERIVED

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

delpazolidBID protein, humanLinezolid

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • T.S Sim, M.D., Ph.D

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 19, 2016

Study Start

December 10, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)