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

NCT01554995 | Completed Phase 1 DMC

• 1 other identifier: LCB01-0371-11-1-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

LCB01-0371

Outcome Measures

Primary Outcomes (1)

• safety and tolerability

  Summary statistics for SAD parts will be prepared for measured values and changes from baseline values for each dose group. Placebo subjects will serve as the control. Summaries of treatment-emergent and clinically important abnormalities in ECG, physical examination, vital signs, and laboratory (clinical chemistry, hematology, coagulation, urinalysis) data will be provided. The incidence of adverse events(AEs) will be tabulated and compared across dose group in the SAD parts.

  7 days

Study Arms (2)

LCB01-0371

EXPERIMENTAL

active

Drug: LCB01-0371

Linezolid

EXPERIMENTAL

comparator

Drug: Linezolid

Interventions

LCB01-0371 DRUG

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

LCB01-0371

Linezolid DRUG

Linezolid 600 mg (Cohort 9) none

Linezolid

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Male between 20 and 45 years of age at the time of screening
• Subjects with body mass index (BMI) between 20 and 27 at the time of screening
• Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days of study completion
• Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

You may not qualify if:

• History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
• History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) 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 of drug abuse or positive result at urine drug screening test
• AST, ALT, r-GT, billirubin(total) values over than 1.5 times of ULN

Sponsors & Collaborators

• LigaChem Biosciences, Inc.: lead

Study Sites (1)

Asan Medical Center

Seoul, 138736, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29712654 DERIVED

MeSH Terms

Interventions

delpazolid; Linezolid

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kyun-Seop Bae, M.D., Ph. D.

  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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 15, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: November 17, 2014

Record last verified: 2013-04

Locations

KR (1)