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Multiple Ascending Dose Study for LCB01-0371

NCT ID: NCT01842516

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-12-31

Brief Summary

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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

Detailed Description

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* To investigate the PK characteristics of LCB01-0371 after a multiple oral dose
* To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LCB01-0371 800mg

LCB01-0371 800mg

Group Type EXPERIMENTAL

LCB01-0371 800mg

Intervention Type DRUG

LCB0-0371 800mg

LCB01-0371 1200mg

LCB01-0371 1200mg

Group Type EXPERIMENTAL

LCB01-0371 1200mg

Intervention Type DRUG

LCB01-0371 1200mg

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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LCB01-0371 800mg

LCB0-0371 800mg

Intervention Type DRUG

LCB01-0371 1200mg

LCB01-0371 1200mg

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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LCB0-0371 800mg

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test
3. Able to donate blood during study period and follow visit.
4. Agree to continue to use a reliable method of birth control until 60 days after study completion.
5. Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion Criteria

1. History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
2. History of gastrointestinal problem 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 drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

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, MD, PhD.

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, 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.

Reference Type DERIVED
PMID: 30420289 (View on PubMed)

Other Identifiers

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LCB01-0371-12-1-02

Identifier Type: -

Identifier Source: org_study_id