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

A Phase I Clinical Study, Multiple Dose of LCB01-0371 in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02540460

Enrollment

Registered

2015-09-04

Start date

2014-06-30

Completion date

2015-01-31

Last updated

2015-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Detailed description

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

Interventions

DRUGLCB01-0371 800mg

LCB01-0371 800mg

DRUGLCB01-0371 800mg BID

LCB01-0371 800mg BID

DRUGLCB01-0371 1200mg BID

LCB01-0371 1200mg BID

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
No of Adverse events	From date of randomization until follow up after 3 days from last hospital discharge

Secondary

Measure	Time frame	Description
Pharmacokinetics: Cmax(Peak plasma concentration)	0(predose), 0.5, 1, 2, 4, 8 and 12hours	Predose date: 1, 3, 6, 9, 12, 15, 17, 19, 20 and 21Days
Pharmacokinetics: AUC(Area under the curve)	0(predose), 0.5, 1, 2, 4, 8 and 12hours	Predose date: 1, 3, 6, 9, 12, 15, 17, 19, 20 and 21Days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026