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Completed

NCT Number: NCT02538003

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

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

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Bundang, Gyeonggi-do, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

LCB01-0371 Tablet 800 mg(R)

Drug

Reference: taken drug before meal

Other names: LCB01-0371 Tablet 400 mg 2 Tablet

LCB01-0371 Tablet 800 mg(T)

Drug

Test: taken drug after meal

Other names: LCB01-0371 Tablet 400 mg 2 Tablet

Primary outcomes

  1. Number of Adverse events

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

Secondary outcomes

  1. Pharmacokinetics: AUClast(Area under the plasma concentration)

    Time frame: 0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours

  2. Pharmacokinetics: Cmax(Peak plasma concentration)

    Time frame: 0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours

Sponsors and collaborators

Lead sponsor

LigaChem Biosciences, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 2, 2015
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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