A Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose Study
This study has been completed.
Sponsor:
LegoChem Biosciences, Inc
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
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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:
- 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
- Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test
- Able to donate blood during study period and follow visit.
- Agree to continue to use a reliable method of birth control until 60 days after study completion.
- Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Exclusion Criteria:
- History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
- History of gastrointestinal problem which is affect to absorption within 6 months from screening
- 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.
- History drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.
- Use of any medication which affect to absorption and elimination within 30 days prior to the Day 1.
- Use of Barbiturates within 30 days prior to the Day 1.
- 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.
- Use of any abnormal meal which affect to adsorption, distribution, metabolism, excretion within 30 days prior to the Day 1.
- Receipt of another investigational medication within 60 days prior to Day 1
- Blood donation (whole blood) within 60 days prior to Day 1. Plasma donation or transfusion within 30 days prior to Day 1.
- Caffeine, alcohol and smoke abuse (caffeine > 5 units/day, alcohol > 21 units/week, tobacco > 10/day)
- Positive findings on HBsAg, Anti-HAV IgM, anti-HCV, HIV Ag, HIV Ab and syphilis high quality regain test
- Subjects deemed ineligible by investigator based on other reasons
Contacts and Locations 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 May 19, 2013