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

November 13, 2014 updated by: LegoChem Biosciences, Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • 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

Study Type

Interventional

Enrollment (Actual)

70

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

Male

Description

Inclusion Criteria:

  1. Healthy Male between 20 and 45 years of age at the time of screening
  2. Subjects with body mass index (BMI) between 20 and 27 at the time of screening
  3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days of study completion
  4. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

Exclusion Criteria:

  1. History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
  2. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) 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 of drug abuse or positive result at urine drug screening test
  5. AST, ALT, r-GT, billirubin(total) values over than 1.5 times of ULN

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: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LCB01-0371
active
Drug: LCB01-0371
LCB01-0371 50mg (Cohort 1) 100mg (Cohort 2) 200mg (Cohort 3) 400mg (Cohort 4) 600mg (Cohort 5)
Experimental: Linezolid
comparator
Drug: Linezolid
Linezolid 600 mg (Cohort 9) none

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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, M.D., Ph. D., 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, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 9, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 15, 2012

Study Record Updates

Last Update Posted (Estimate)

November 17, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCB01-0371-11-1-01

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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