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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LegoChem Biosciences, Inc
ClinicalTrials.gov Identifier:
NCT01554995
First received: March 9, 2012
Last updated: April 20, 2013
Last verified: April 2013
  Purpose

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

Condition Intervention Phase
Healthy
Drug: LCB01-0371
Drug: Linezolid
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by LegoChem Biosciences, Inc:

Primary Outcome Measures:
  • safety and tolerability [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 70
Study Start Date: March 2012
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCB01-0371
active
Drug: LCB01-0371
LCB01-0371 50mg (Cohort 1) 100mg (Cohort 2) 200mg (Cohort 3) 400mg (Cohort 4) 600mg (Cohort 5)
Other Name: LCB01-0371
Experimental: Linezolid
comparator
Drug: Linezolid
Linezolid 600 mg (Cohort 9) none
Other Name: Linezolid

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
  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  5. Use of any medication which affect to absorption and elimination within 30 days prior to the Day 1.
  6. Use of Barbiturates within 30 days prior to the Day 1.
  7. Use of any herbal products within 30 days or prescription medication within 14 days or over-the-counter medication within 7 days prior to the Day 1.
  8. Use of any abnormal meal which affect to adsorption, distribution, metabolism, excretion within 30 days prior to the Day 1.
  9. Receipt of another investigational medication within 60 days prior to Day 1
  10. Blood donation (whole blood) within 60 days prior to Day 1. Plasma donation or transfusion within 30 days prior to Day 1.
  11. Caffeine, alcohol and smoke abuse (caffeine > 5 units/day, alcohol > 21 units/week, tobacco > 10/day)
  12. Positive findings on HBsAg, Anti-HAV IgM, anti-HCV, HIV Ag, HIV Ab and syphilis high quality regain test
  13. Subjects deemed ineligible by investigator based on other reasons
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554995

Locations
Korea, Republic of
Asan Medical Center
Seoul,, Korea, Republic of, 138736
Sponsors and Collaborators
LegoChem Biosciences, Inc
Investigators
Principal Investigator: Kyun-Seop Bae, M.D., Ph. D. Asan Medical Center
  More Information

No publications provided

Responsible Party: LegoChem Biosciences, Inc
ClinicalTrials.gov Identifier: NCT01554995     History of Changes
Other Study ID Numbers: LCB01-0371-11-1-01
Study First Received: March 9, 2012
Last Updated: April 20, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by LegoChem Biosciences, Inc:
LCB01-0371

Additional relevant MeSH terms:
Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014