NCT02529241

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jul 2015

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 12, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

5 months

First QC Date

August 12, 2015

Last Update Submit

April 7, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Number of Adverse Event

    participants will be followed after hospital stay, an expected average of 16 weeks

Study Arms (2)

Group 1: LCB01-0371

EXPERIMENTAL

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

Drug: Group 1:LCB01-0371Drug: Group 2:LCB01-0371

Group 2: LCB01-0371

EXPERIMENTAL

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

Drug: Group 1:LCB01-0371Drug: Group 2:LCB01-0371

Interventions

Group 1:LCB01-0371DRUG

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

Group 1: LCB01-0371Group 2: LCB01-0371
Group 2:LCB01-0371DRUG

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

Group 1: LCB01-0371Group 2: LCB01-0371

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male between 20 and 40 years of age at the time of screening
  • 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
  • Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

You may not qualify if:

  • 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)
  • 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
  • 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)
  • blood donation and transfusion within 60 days prior to screening visit
  • Treatment with an other investigational product or Participation in other bioequivalence test within 90 days prior to screening visit
  • Use medication which expected to influence in this study within 30 days prior to screening visit
  • 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
  • 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
  • positive result at urine drug screening test or urine nicotine test at screening visit
  • positive result at serum test(hepatitis B, hepatitis C, HIV, syphilis) at screening visit
  • corrected QT interval \>450 msec or significant abnormalities on screening ECG
  • other: Patients considered unable perform for the study by the investigator concerning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Study Officials

  • Kyun-Seop Bae, MD PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2015

First Posted

August 20, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 8, 2016

Record last verified: 2016-04

Locations

KR(1)