To Evaluate the Effect of Food on Pharmacokinetics(PK), Phase I Clinical Study of LCB01-0371

A Randomized, Open-label, Single Dose, Crossover, Phase Ⅰ Trial to Evaluate the Effect of Food on the Pharmacokinetics of LCB01-0371 in Healthy Male Subjects

The purpose of this study is to assess safety, tolerability of LCB01-0371 after fasting/non-fasting food taken in healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LCB01-0371 Tablet 800 mg(R); Drug: LCB01-0371 Tablet 800 mg(T)

Detailed Description

A Randomized, Open-label, Single dose, Crossover, Phase Ⅰ Trial to evaluate the effect of food on the pharmacokinetics of LCB01-0371 in healthy male subjects.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Bundang, Gyeonggi, Korea, Republic of
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Healthy male between 20 and 40 years of age at the time of screening with body mass index (BMI) between 19 kg/m2 and 28 kg/m2 at the time of screening
2. Appropriated for a medical examination by interview,Vital sign,physical examination, local laboratory test result and 12-lead ECG
3. Capable of performing follow up visit, blood sampling
4. 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
5. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

Exclusion Criteria:

1. History of clinically significant disease such as digestive system, respiratory, musculoskeletal, cardiovascular, endocrine, neuropsychiatry, hematology, cardiovascular system
2. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 180 days possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
3. 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(except non active allergic rhinitis)
4. History of drug abuse or positive result at urine drug screening test at screening visit
5. Intake drug which expected to chronic influence of drug absorption or elimination within 30 days prior to screening visit
6. Other: Patients considered unable perform for the study by the investigator concerning

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1(RT):LCB01-0371 Tablet 800mg; Period:LCB01-0371 Tablet 800mg(Reference: Taken drug before meal); Period: LCB01-0371 Tablet 800 mg(Test: Taken drug after meal)	Drug: LCB01-0371 Tablet 800 mg(R); Reference: taken drug before meal; Other Names: LCB01-0371 Tablet 400 mg 2 Tablet; Drug: LCB01-0371 Tablet 800 mg(T); Test: taken drug after meal; Other Names: LCB01-0371 Tablet 400 mg 2 Tablet
Experimental: Group 2(TR):LCB01-0371 Tablet 800mg; Period:LCB01-0371 Tablet 800mg(Test:taken drug after meal); Period: LCB01-0371 Tablet 800 mg(Reference:taken drug before meal)	Drug: LCB01-0371 Tablet 800 mg(R); Reference: taken drug before meal; Other Names: LCB01-0371 Tablet 400 mg 2 Tablet; Drug: LCB01-0371 Tablet 800 mg(T); Test: taken drug after meal; Other Names: LCB01-0371 Tablet 400 mg 2 Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Adverse events	From date of randomization until follow up after 7 days from last hospital discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: AUClast(Area under the plasma concentration)	0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours
Pharmacokinetics: Cmax(Peak plasma concentration)	0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours

Collaborators and Investigators

• Sponsor: LegoChem Biosciences, Inc
• Investigators: Principal Investigator: Jaeyong Chung, M.D., Ph.D, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Estimate): March 23, 2016
• Last Update Submitted That Met QC Criteria: March 22, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Delpazolid; Oxazolidinones
• Other Study ID Numbers: LCB01-0371-13-1-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO