NCT01842516

Brief Summary

Primary

  • To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose
  • To investigate the pharmacokinetic characteristics of LCB01-0371 after a multiple oral dose in healthy male subjects
  • To investigate the safety 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 Mar 2013

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

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

4 months

First QC Date

April 20, 2013

Last Update Submit

November 14, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    Up to 7 days

Secondary Outcomes (2)

  • Area under the plasma concentration versus time curve (AUC) of LCB01-0371

    Up to 7 days

  • Peak Plasma Concentration (Cmax) of LCB01-0371

    Up to 7 days

Study Arms (3)

LCB01-0371 800mg

EXPERIMENTAL

LCB01-0371 800mg

Drug: LCB01-0371 800mg

LCB01-0371 1200mg

EXPERIMENTAL

LCB01-0371 1200mg

Drug: LCB01-0371 1200mg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

LCB01-0371 800mgDRUG

LCB0-0371 800mg

Also known as: LCB0-0371 800mg
LCB01-0371 800mg
LCB01-0371 1200mgDRUG

LCB01-0371 1200mg

LCB01-0371 1200mg
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Cho YS, Lim HS, Cho YL, Nam HS, Bae KS. Multiple-dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral LCB01-0371 in Healthy Male Volunteers. Clin Ther. 2018 Dec;40(12):2050-2064. doi: 10.1016/j.clinthera.2018.10.007. Epub 2018 Nov 10.

    PMID: 30420289DERIVED

MeSH Terms

Interventions

delpazolid

Study Officials

  • Kyun-Seop Bae, MD, PhD.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2013

First Posted

April 29, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2013

Study Completion

December 1, 2013

Last Updated

November 17, 2014

Record last verified: 2014-11

Locations

KR(1)