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A Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose Study

NCT ID: NCT01554995

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-02-28

Brief Summary

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Primary

\- To investigate the safety and tolerability of LCB01-0371 after a single oral dose

Secondary

* To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral dose
* To investigate the safety of LCB01-0371 after a single oral dose

Detailed Description

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* To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral dose
* To investigate the safety of LCB01-0371 after a single oral dose

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LCB01-0371

active

Group Type EXPERIMENTAL

LCB01-0371

Intervention Type DRUG

LCB01-0371 50mg (Cohort 1) 100mg (Cohort 2) 200mg (Cohort 3) 400mg (Cohort 4) 600mg (Cohort 5)

Linezolid

comparator

Group Type EXPERIMENTAL

Linezolid

Intervention Type DRUG

Linezolid 600 mg (Cohort 9) none

Interventions

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LCB01-0371

LCB01-0371 50mg (Cohort 1) 100mg (Cohort 2) 200mg (Cohort 3) 400mg (Cohort 4) 600mg (Cohort 5)

Intervention Type DRUG

Linezolid

Linezolid 600 mg (Cohort 9) none

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy Male between 20 and 45 years of age at the time of screening
2. Subjects with body mass index (BMI) between 20 and 27 at the time of screening
3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days of study completion
4. 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 liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
2. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption within 6 months from screening
3. 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.
4. History of drug abuse or positive result at urine drug screening test
5. AST, ALT, r-GT, billirubin(total) values over than 1.5 times of ULN
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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LigaChem Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyun-Seop Bae, M.D., Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Cho YS, Lim HS, Lee SH, Cho YL, Nam HS, Bae KS. Pharmacokinetics, Pharmacodynamics, and Tolerability of Single-Dose Oral LCB01-0371, a Novel Oxazolidinone with Broad-Spectrum Activity, in Healthy Volunteers. Antimicrob Agents Chemother. 2018 Jun 26;62(7):e00451-18. doi: 10.1128/AAC.00451-18. Print 2018 Jul.

Reference Type DERIVED
PMID: 29712654 (View on PubMed)

Other Identifiers

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LCB01-0371-11-1-01

Identifier Type: -

Identifier Source: org_study_id