An Open-label, Single Dose, Parallel Design, Phase 1 Clinical Study of LCB01-0371

Study Overview
=================
Brief Summary
-----------------
To investigate pharmacokinetics, safety and tolerability of LCB01-0371, LCB01-0371-B after a single oral dose in healthy male subjects. To investigate safety, tolerability of LCB01-0371 after a single oral dose in healthy male subjects.

Detailed Description
-----------------
An Open-label, Single dose, Parallel design, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Oral dosage form of LCB01-0371 in Healthy Male Volunteers

Official Title
-----------------
An Open-label, Single Dose, Parallel Design, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Oral Dosage Form of LCB01-0371 in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Group 1:LCB01-0371
* Drug: Group 2:LCB01-0371


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male between 20 and 40 years of age at the time of screening Agree to continue to use a medically reliable dual contraception and not to donate sperm in this protocol for the duration of the study and for 28 days after last dose of investigational product Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements Exclusion Criteria: History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 6 months possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy) History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics History of clinically significant disease such as allergic or anaphylactic reaction to drug, cardiovascular, peripheral vascular system, skin, mucous membrane, eye, otorhinolaryngologic system, respiratory, musculoskeletal, infection disease, Gastrointestinal system , liver, biliary system, endocrine, kidney, urogenital system, nervous system, psychiatric system, blood dyscrasia, tumor, fracture, problem(s) blood donation and transfusion within 60 days prior to screening visit Treatment with an other investigational product or Participation in other bioequivalence test within 90 days prior to screening visit Use medication which expected to influence in this study within 30 days prior to screening visit smokers over 10 cigarettes per day within 30 days prior to screening visit or unable to stop smoking in this protocol for the duration of the study from first dose of investigational product drinkers over 3 glasses alcohol drink per week within 30 days prior to screening visit or unable to stop drinking in this protocol for the duration of the study from first dose of investigational product positive result at urine drug screening test or urine nicotine test at screening visit positive result at serum test(hepatitis B, hepatitis C, HIV, syphilis) at screening visit corrected QT interval >450 msec or significant abnormalities on screening ECG other: Patients considered unable perform for the study by the investigator concerning

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: LCB01-0371<br>Period 1: LCB01-0371 Tablet 400 mg Period 2: LCB01-0371 Tablet 400 mg | Drug: Group 1:LCB01-0371<br>* Period:LCB01-0371 Tablet 400 mg Period: LCB01-0371 Tablet 400 mg<br>Drug: Group 2:LCB01-0371<br>* Period:LCB01-0371 Tablet 800 mg Period: LCB01-0371 Tablet 1200 mg<br>|
| Experimental: Group 2: LCB01-0371<br>Period 1: LCB01-0371 Tablet 800 mg Period 2: LCB01-0371 Tablet 1200 mg | Drug: Group 1:LCB01-0371<br>* Period:LCB01-0371 Tablet 400 mg Period: LCB01-0371 Tablet 400 mg<br>Drug: Group 2:LCB01-0371<br>* Period:LCB01-0371 Tablet 800 mg Period: LCB01-0371 Tablet 1200 mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Peak Plasma Concentration (Cmax) |  | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours | 
| Pharmacokinetics: time to maximum concentration (Tmax) |  | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours | 
| Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) |  | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Event |  | participants will be followed after hospital stay, an expected average of 16 weeks |