An Open-label, Single Dose, Parallel Design, Phase 1 Clinical Study of LCB01-0371

An Open-label, Single Dose, Parallel Design, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Oral Dosage Form of LCB01-0371 in Healthy Volunteers

To investigate pharmacokinetics, safety and tolerability of LCB01-0371, LCB01-0371-B after a single oral dose in healthy male subjects.

To investigate safety, tolerability of LCB01-0371 after a single oral dose in healthy male subjects.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: Group 1:LCB01-0371; Drug: Group 2:LCB01-0371

Detailed Description

An Open-label, Single dose, Parallel design, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Oral dosage form of LCB01-0371 in Healthy Male Volunteers

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male between 20 and 40 years of age at the time of screening
2. Agree to continue to use a medically reliable dual contraception and not to donate sperm in this protocol for the duration of the study and for 28 days after last dose of investigational product
3. 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 gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 6 months possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
2. History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics
3. History of clinically significant disease such as allergic or anaphylactic reaction to drug, cardiovascular, peripheral vascular system, skin, mucous membrane, eye, otorhinolaryngologic system, respiratory, musculoskeletal, infection disease, Gastrointestinal system , liver, biliary system, endocrine, kidney, urogenital system, nervous system, psychiatric system, blood dyscrasia, tumor, fracture, problem(s)
4. blood donation and transfusion within 60 days prior to screening visit
5. Treatment with an other investigational product or Participation in other bioequivalence test within 90 days prior to screening visit
6. Use medication which expected to influence in this study within 30 days prior to screening visit
7. smokers over 10 cigarettes per day within 30 days prior to screening visit or unable to stop smoking in this protocol for the duration of the study from first dose of investigational product
8. drinkers over 3 glasses alcohol drink per week within 30 days prior to screening visit or unable to stop drinking in this protocol for the duration of the study from first dose of investigational product
9. positive result at urine drug screening test or urine nicotine test at screening visit
10. positive result at serum test(hepatitis B, hepatitis C, HIV, syphilis) at screening visit
11. corrected QT interval >450 msec or significant abnormalities on screening ECG
12. other: Patients considered unable perform for the study by the investigator concerning

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: LCB01-0371; Period 1: LCB01-0371 Tablet 400 mg Period 2: LCB01-0371 Tablet 400 mg	Drug: Group 1:LCB01-0371; Period:LCB01-0371 Tablet 400 mg; Period: LCB01-0371 Tablet 400 mg; Drug: Group 2:LCB01-0371; Period:LCB01-0371 Tablet 800 mg; Period: LCB01-0371 Tablet 1200 mg
Experimental: Group 2: LCB01-0371; Period 1: LCB01-0371 Tablet 800 mg Period 2: LCB01-0371 Tablet 1200 mg	Drug: Group 1:LCB01-0371; Period:LCB01-0371 Tablet 400 mg; Period: LCB01-0371 Tablet 400 mg; Drug: Group 2:LCB01-0371; Period:LCB01-0371 Tablet 800 mg; Period: LCB01-0371 Tablet 1200 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Peak Plasma Concentration (Cmax)	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
Pharmacokinetics: time to maximum concentration (Tmax)	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Adverse Event	participants will be followed after hospital stay, an expected average of 16 weeks

Collaborators and Investigators

• Sponsor: LegoChem Biosciences, Inc
• Investigators: Principal Investigator: Kyun-Seop Bae, MD PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 12, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 20, 2015

Study Record Updates

• Last Update Posted (Estimate): April 8, 2016
• Last Update Submitted That Met QC Criteria: April 7, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Delpazolid; Oxazolidinones
• Other Study ID Numbers: LCB01-0371-15-1-01