Multiple Ascending Dose Study for LCB01-0371 | NCT01842516

Studies
Multiple Ascending Dose Study for LCB01-0371

NCT01842516

Sponsor

LigaChem Biosciences, Inc.

Status

Completed

Last Update Posted

Nov 17, 2014Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

LCB01-0371 800mg
LCB01-0371 1200mg
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Jul 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Apr 20, 2013

First Submission Date that Met QC Criteria

Apr 24, 2013

First Posted Date

Apr 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2014

Last Update Posted Date

Nov 17, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Primary

To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose
To investigate the pharmacokinetic characteristics of LCB01-0371 after a multiple oral dose in healthy male subjects
To investigate the safety of LCB01-0371 after a multiple oral dose in healthy male subjects

Detailed Description

To investigate the PK characteristics of LCB01-0371 after a multiple oral dose
To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LCB01-0371 800mg	Experimental	LCB01-0371 800mg	Drug: LCB01-0371 800mg
LCB01-0371 1200mg	Experimental	LCB01-0371 1200mg	Drug: LCB01-0371 1200mg
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LCB01-0371 800mg	Drug	LCB0-0371 800mg	LCB01-0371 800mg	LCB0-0371 800mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events		Up to 7 days

Secondary Outcomes

Measure	Description	Time Frame
Area under the plasma concentration versus time curve (AUC) of LCB01-0371		Up to 7 days
Peak Plasma Concentration (Cmax) of LCB01-0371		Up to 7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Health Male between 20 and 45 years of age at the time of screening and a subject with body mass index (BMI) between 19 and 27
Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test
Able to donate blood during study period and follow visit.
Agree to continue to use a reliable method of birth control until 60 days after study completion.
Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion Criteria:

History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
History of gastrointestinal problem which is affect to absorption within 6 months from screening
History of hypersensitivity or clinically significant adverse drug reaction(s) to the LCB01-0371, same class of the study drugs (linezolid), or other drugs including aspirin and antibiotics.
History drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kyun-Seop Bae, MD, PhD.	Asan Medical Center	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30420289	Derived	Cho YS, Lim HS, Cho YL, Nam HS, Bae KS. Multiple-dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral LCB01-0371 in Healthy Male Volunteers. Clin Ther. 2018 Dec;40(12):2050-2064. doi: 10.1016/j.clinthera.2018.10.007. Epub 2018 Nov 10.