Multiple Ascendoing Dose Study for LCB01-0371

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by LegoChem Biosciences, Inc
Sponsor:
Information provided by (Responsible Party):
LegoChem Biosciences, Inc
ClinicalTrials.gov Identifier:
NCT01842516
First received: April 20, 2013
Last updated: April 24, 2013
Last verified: April 2013
  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
  • To investigate the safety of LCB01-0371 after a multiple oral dose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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, Pharmacokinetics and Pharmacodynamics 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) of LCB01-0371 [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
  • Peak Plasma Concentration (Cmax) of LCB01-0371 [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2013
Estimated Study Completion Date: December 2013
Estimated 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
Other Name: LCB01-0371 1200mg
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Other Name: 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

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
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
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: NCT01842516

Contacts
Contact: Kyun-Seop Bae, , MD, PhD.

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kyun-Seop Bae, M.D., Ph.D.    82-2-3010-4611    ksbae@amc.seoul.kr   
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D.         
Sponsors and Collaborators
LegoChem Biosciences, Inc
Investigators
Principal Investigator: Kyun-Seop Bae, MD, PhD. Asan Medical Center
  More Information

No publications provided

Responsible Party: LegoChem Biosciences, Inc
ClinicalTrials.gov Identifier: NCT01842516     History of Changes
Other Study ID Numbers: LCB01-0371-12-1-02
Study First Received: April 20, 2013
Last Updated: April 24, 2013
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014