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

NCT02538003 | Completed Phase 1

• 1 other identifier: LCB01-0371-13-1-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Adverse events

  From date of randomization until follow up after 7 days from last hospital discharge

Secondary Outcomes (2)

• 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

Study Arms (2)

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

EXPERIMENTAL

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

Drug: LCB01-0371 Tablet 800 mg(R); Drug: LCB01-0371 Tablet 800 mg(T)

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

EXPERIMENTAL

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

Drug: LCB01-0371 Tablet 800 mg(R); Drug: LCB01-0371 Tablet 800 mg(T)

Interventions

LCB01-0371 Tablet 800 mg(R) DRUG

Reference: taken drug before meal

Also known as: LCB01-0371 Tablet 400 mg 2 Tablet

Group 1(RT):LCB01-0371 Tablet 800mg; Group 2(TR):LCB01-0371 Tablet 800mg

LCB01-0371 Tablet 800 mg(T) DRUG

Test: taken drug after meal

Also known as: LCB01-0371 Tablet 400 mg 2 Tablet

Group 1(RT):LCB01-0371 Tablet 800mg; Group 2(TR):LCB01-0371 Tablet 800mg

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Appropriated for a medical examination by interview,Vital sign,physical examination, local laboratory test result and 12-lead ECG
• Capable of performing follow up visit, blood sampling
• 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

You may not qualify if:

• History of clinically significant disease such as digestive system, respiratory, musculoskeletal, cardiovascular, endocrine, neuropsychiatry, hematology, cardiovascular system
• 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)
• 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)
• History of drug abuse or positive result at urine drug screening test at screening visit
• Intake drug which expected to chronic influence of drug absorption or elimination within 30 days prior to screening visit
• Other: Patients considered unable perform for the study by the investigator concerning

Sponsors & Collaborators

• LigaChem Biosciences, Inc.: lead

Study Sites (1)

Seoul National University Bundang Hospital

Bundang, Gyeonggi-do, South Korea

Location

MeSH Terms

Interventions

delpazolid

Study Officials

• Jaeyong Chung, M.D., Ph.D

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 2, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 23, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)