Multiple Ascending Dose Study for LCB01-0371

November 14, 2014 updated by: LegoChem Biosciences, Inc

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • 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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test
  3. Able to donate blood during study period and follow visit.
  4. Agree to continue to use a reliable method of birth control until 60 days after study completion.
  5. Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion Criteria:

  1. History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
  2. History of gastrointestinal problem which is affect to absorption within 6 months from screening
  3. 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.
  4. History drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: LCB01-0371 800mg
Drug: LCB01-0371 800mg
LCB0-0371 800mg
Other Names:
  • LCB0-0371 800mg
Experimental: LCB01-0371 1200mg
Drug: LCB01-0371 1200mg
LCB01-0371 1200mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: Up to 7 days
Up to 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration versus time curve (AUC) of LCB01-0371
Time Frame: Up to 7 days
Up to 7 days
Peak Plasma Concentration (Cmax) of LCB01-0371
Time Frame: Up to 7 days
Up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LegoChem Biosciences, Inc

Investigators

  • Principal Investigator: Kyun-Seop Bae, MD, PhD., Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 20, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimate)

April 29, 2013

Study Record Updates

Last Update Posted (Estimate)

November 17, 2014

Last Update Submitted That Met QC Criteria

November 14, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCB01-0371-12-1-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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