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Multiple Ascending Dose Study for LCB01-0371

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01842516
First Posted: April 29, 2013
Last Update Posted: November 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LegoChem Biosciences, Inc
  Purpose

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

Condition Intervention Phase
Healthy Drug: LCB01-0371 800mg Drug: LCB01-0371 1200mg Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.

Further study details as provided by LegoChem Biosciences, Inc:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Up to 7 days ]

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

Enrollment: 30
Study Start Date: March 2013
Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCB01-0371 800mg
LCB01-0371 800mg
Drug: LCB01-0371 800mg
LCB0-0371 800mg
Other Name: LCB0-0371 800mg
Experimental: LCB01-0371 1200mg
LCB01-0371 1200mg
Drug: LCB01-0371 1200mg
LCB01-0371 1200mg
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842516


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

Responsible Party: LegoChem Biosciences, Inc
ClinicalTrials.gov Identifier: NCT01842516     History of Changes
Other Study ID Numbers: LCB01-0371-12-1-02
First Submitted: April 20, 2013
First Posted: April 29, 2013
Last Update Posted: November 17, 2014
Last Verified: November 2014