Multiple Ascending Dose, Phase 1 Clinical Study of LCB01-0371

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

2014-06-30

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Double blind, randomized, placebo control, multiple dose, dose escalation study

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

DOUBLE

Participants Investigators

Study Groups

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LCB01-0371 800mg

Group Type EXPERIMENTAL

LCB01-0371 800mg

Intervention Type DRUG

LCB01-0371 800mg

Placebo

Intervention Type DRUG

Placebo

LCB01-0371 800mg BID

Group Type EXPERIMENTAL

LCB01-0371 800mg BID

Intervention Type DRUG

LCB01-0371 800mg BID

Placebo

Intervention Type DRUG

Placebo

LCB01-0371 1200mg BID

Group Type EXPERIMENTAL

LCB01-0371 1200mg BID

Intervention Type DRUG

LCB01-0371 1200mg BID

Placebo

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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LCB01-0371 800mg

Intervention Type DRUG

LCB01-0371 800mg BID

Intervention Type DRUG

LCB01-0371 1200mg BID

Intervention Type DRUG

Placebo

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 kg/m2 and 27 kg/m2 at the time of screening
3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days after 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, alimentary, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncologic, cardiovascular problem(s)
2. 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)
3. 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
4. History of drug abuse or positive result at urine drug screening
5. AST, ALT, r-GT, bilirubin(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