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OpenTrials
Completed

NCT Number: NCT01554995

A Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose Study

Primary

- To investigate the safety and tolerability of LCB01-0371 after a single oral dose

Secondary

* To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral dose * To investigate the safety of LCB01-0371 after a single oral dose

Completed

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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

Asan Medical Center

Seoul, 138736, South Korea

About this study

  • To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral dose
  • To investigate the safety of LCB01-0371 after a single oral dose

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 and 27 at the time of screening
  • Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days of 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, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
  • History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption within 6 months from screening
  • History of hypersensitivity or clinically significant adverse drug reaction(s) to the LCB01-0371, 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 test
  • AST, ALT, r-GT, billirubin(total) values over than 1.5 times of ULN

Treatment and study plan

LCB01-0371

Drug

LCB01-0371 50mg (Cohort 1) 100mg (Cohort 2) 200mg (Cohort 3) 400mg (Cohort 4) 600mg (Cohort 5)

Linezolid

Drug

Linezolid 600 mg (Cohort 9) none

Primary outcomes

  1. safety and tolerability

    Time frame: 7 days

    Summary statistics for SAD parts will be prepared for measured values and changes from baseline values for each dose group. Placebo subjects will serve as the control. Summaries of treatment-emergent and clinically important abnormalities in ECG, physical examination, vital signs, and laboratory (clinical chemistry, hematology, coagulation, urinalysis) data will be provided. The incidence of adverse events(AEs) will be tabulated and compared across dose group in the SAD parts.

Sponsors and collaborators

Lead sponsor

LigaChem Biosciences, Inc.

Industry

Registry information

Official study title

A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCB01-0371 in Healthy Male Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Mar 15, 2012
Registry last updated
Nov 17, 2014

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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