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Completed

NCT Number: NCT01842516

Multiple Ascending Dose Study for LCB01-0371

Primary

* To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose * To investigate the pharmacokinetic characteristics of LCB01-0371 after a multiple oral dose in healthy male subjects * To investigate the safety of LCB01-0371 after a multiple oral dose in healthy male subjects

Completed

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

About this study

  • To investigate the PK characteristics of LCB01-0371 after a multiple oral dose
  • To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Health Male between 20 and 45 years of age at the time of screening and a subject with body mass index (BMI) between 19 and 27
  • Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test
  • Able to donate blood during study period and follow visit.
  • Agree to continue to use a reliable method of birth control until 60 days after study completion.
  • Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion criteria

  • History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
  • History of gastrointestinal problem 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 drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.

Treatment and study plan

LCB01-0371 800mg

Drug

LCB0-0371 800mg

Other names: LCB0-0371 800mg

LCB01-0371 1200mg

Drug

LCB01-0371 1200mg

Placebo

Drug

Placebo

Primary outcomes

  1. Number of participants with adverse events

    Time frame: Up to 7 days

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of LCB01-0371

    Time frame: Up to 7 days

  2. Peak Plasma Concentration (Cmax) of LCB01-0371

    Time frame: Up to 7 days

Sponsors and collaborators

Lead sponsor

LigaChem Biosciences, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 29, 2013
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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