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

NCT ID: NCT02538003

Last Updated: 2016-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-12-31

Brief Summary

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

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1(RT):LCB01-0371 Tablet 800mg

1. Period:LCB01-0371 Tablet 800mg(Reference: Taken drug before meal)

2. Period: LCB01-0371 Tablet 800 mg(Test: Taken drug after meal)

Group Type: EXPERIMENTAL

LCB01-0371 Tablet 800 mg(R)

Intervention Type: DRUG

Reference: taken drug before meal

LCB01-0371 Tablet 800 mg(T)

Intervention Type: DRUG

Test: taken drug after meal

Group 2(TR):LCB01-0371 Tablet 800mg

1. Period:LCB01-0371 Tablet 800mg(Test:taken drug after meal)

2. Period: LCB01-0371 Tablet 800 mg(Reference:taken drug before meal)

Group Type: EXPERIMENTAL

LCB01-0371 Tablet 800 mg(R)

Intervention Type: DRUG

Reference: taken drug before meal

LCB01-0371 Tablet 800 mg(T)

Intervention Type: DRUG

Test: taken drug after meal

Interventions

LCB01-0371 Tablet 800 mg(R)

Reference: taken drug before meal

Intervention Type: DRUG

LCB01-0371 Tablet 800 mg(T)

Test: taken drug after meal

Intervention Type: DRUG

Other Intervention Names

LCB01-0371 Tablet 400 mg 2 Tablet; LCB01-0371 Tablet 400 mg 2 Tablet

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

LigaChem Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaeyong Chung, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Bundang, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

LCB01-0371-13-1-03

Identifier Type: -

Identifier Source: org_study_id