NCT02540460

Brief Summary

The purpose of this study is to investigate the population pharmacokinetics of LCB01-0371 after a multiple oral dose in healthy male subjects. To investigate safety, tolerability of LCB01-0371 after a multiple oral dose in healthy male subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jun 2014

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

November 13, 2014

Last Update Submit

September 1, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • No of Adverse events

    From date of randomization until follow up after 3 days from last hospital discharge

Secondary Outcomes (2)

  • Pharmacokinetics: Cmax(Peak plasma concentration)

    0(predose), 0.5, 1, 2, 4, 8 and 12hours

  • Pharmacokinetics: AUC(Area under the curve)

    0(predose), 0.5, 1, 2, 4, 8 and 12hours

Study Arms (4)

LCB01-0371 800mg

EXPERIMENTAL

LCB01-0371 800mg

Drug: LCB01-0371 800mgDrug: Placebo

LCB01-0371 800mg BID

EXPERIMENTAL

LCB01-0371 800mg BID

Drug: LCB01-0371 800mg BIDDrug: Placebo

LCB01-0371 1200mg BID

EXPERIMENTAL

LCB01-0371 1200mg BID

Drug: LCB01-0371 1200mg BIDDrug: Placebo

Placebo

PLACEBO COMPARATOR

LCB01-0371 800mg, LCB01-0371 800mg BID, LCB01-0371 1200mg BID

Drug: Placebo

Interventions

LCB01-0371 800mgDRUG

LCB01-0371 800mg

LCB01-0371 800mg
LCB01-0371 800mg BIDDRUG

LCB01-0371 800mg BID

LCB01-0371 800mg BID
LCB01-0371 1200mg BIDDRUG

LCB01-0371 1200mg BID

LCB01-0371 1200mg BID
PlaceboDRUG

Placebo

LCB01-0371 1200mg BIDLCB01-0371 800mgLCB01-0371 800mg BIDPlacebo

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male between 20 and 45 years of age at the time of screening
  • Subjects with body mass index (BMI) between 20 kg/m2 and 27 kg/m2 at the time of screening
  • Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days after study completion
  • 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 liver, kidney, alimentary, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncologic, cardiovascular problem(s)
  • 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 drug abuse or positive result at urine drug screening
  • AST, ALT, r-GT, bilirubin(total) values over than 1.5 times of ULN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Bundang, Gyeonggi-do, South Korea

Location

Related Publications (1)

  • Choi Y, Lee SW, Kim A, Jang K, Nam H, Cho YL, Yu KS, Jang IJ, Chung JY. Safety, tolerability and pharmacokinetics of 21 day multiple oral administration of a new oxazolidinone antibiotic, LCB01-0371, in healthy male subjects. J Antimicrob Chemother. 2018 Jan 1;73(1):183-190. doi: 10.1093/jac/dkx367.

    PMID: 29069400DERIVED

MeSH Terms

Interventions

delpazolidBID protein, human

Study Officials

  • Young Lag Cho, Ph.D.

    Legochembioscience

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2014

First Posted

September 4, 2015

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

September 4, 2015

Record last verified: 2015-09

Locations

KR(1)