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Completed

NCT Number: NCT02540460

Multiple Ascending Dose, Phase 1 Clinical Study of LCB01-0371

The purpose of this study is to investigate the population pharmacokinetics of LCB01-0371 after a multiple oral dose in healthy male subjects.

To investigate safety, tolerability of LCB01-0371 after a multiple oral dose in healthy male subjects.

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Key information

Conditions

Healthy

Age range

20 year–45 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

Double blind, randomized, placebo control, multiple dose, dose escalation study

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 45 years of age at the time of screening
  • Subjects with body mass index (BMI) between 20 kg/m2 and 27 kg/m2 at the time of screening
  • Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days after study completion
  • 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 liver, kidney, alimentary, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncologic, cardiovascular problem(s)
  • 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 drug abuse or positive result at urine drug screening
  • AST, ALT, r-GT, bilirubin(total) values over than 1.5 times of ULN

Treatment and study plan

LCB01-0371 800mg

Drug

LCB01-0371 800mg

LCB01-0371 800mg BID

Drug

LCB01-0371 800mg BID

LCB01-0371 1200mg BID

Drug

LCB01-0371 1200mg BID

Placebo

Drug

Placebo

Primary outcomes

  1. No of Adverse events

    Time frame: From date of randomization until follow up after 3 days from last hospital discharge

Secondary outcomes

  1. Pharmacokinetics: Cmax(Peak plasma concentration)

    Time frame: 0(predose), 0.5, 1, 2, 4, 8 and 12hours

    Predose date: 1, 3, 6, 9, 12, 15, 17, 19, 20 and 21Days

  2. Pharmacokinetics: AUC(Area under the curve)

    Time frame: 0(predose), 0.5, 1, 2, 4, 8 and 12hours

    Predose date: 1, 3, 6, 9, 12, 15, 17, 19, 20 and 21Days

Sponsors and collaborators

Lead sponsor

LigaChem Biosciences, Inc.

Industry

Registry information

Official study title

A Phase I Clinical Study, Multiple Dose of LCB01-0371 in Healthy Male Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 4, 2015
Registry last updated
Sep 4, 2015

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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