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

NCT ID: NCT02529241

Last Updated: 2016-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-12-31

Brief Summary

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.

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

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: LCB01-0371

Period 1: LCB01-0371 Tablet 400 mg Period 2: LCB01-0371 Tablet 400 mg

Group Type: EXPERIMENTAL

Group 1:LCB01-0371

Intervention Type: DRUG

1. Period:LCB01-0371 Tablet 400 mg

2. Period: LCB01-0371 Tablet 400 mg

Group 2:LCB01-0371

Intervention Type: DRUG

1. Period:LCB01-0371 Tablet 800 mg

2. Period: LCB01-0371 Tablet 1200 mg

Group 2: LCB01-0371

Period 1: LCB01-0371 Tablet 800 mg Period 2: LCB01-0371 Tablet 1200 mg

Group Type: EXPERIMENTAL

Group 1:LCB01-0371

Intervention Type: DRUG

1. Period:LCB01-0371 Tablet 400 mg

2. Period: LCB01-0371 Tablet 400 mg

Group 2:LCB01-0371

Intervention Type: DRUG

1. Period:LCB01-0371 Tablet 800 mg

2. Period: LCB01-0371 Tablet 1200 mg

Interventions

Group 1:LCB01-0371

1. Period:LCB01-0371 Tablet 400 mg

2. Period: LCB01-0371 Tablet 400 mg

Intervention Type: DRUG

Group 2:LCB01-0371

1. Period:LCB01-0371 Tablet 800 mg

2. Period: LCB01-0371 Tablet 1200 mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LigaChem Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyun-Seop Bae, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

LCB01-0371-15-1-01

Identifier Type: -

Identifier Source: org_study_id