Completed
A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability, and Population Pharmacokinetics of LCB01-0371 in Healthy Male Subjects.
What is being tested
LCB01-0371 800mg
+ LCB01-0371 1200mg
+ Placebo
Drug
Who is being recruted
From 20 to 45 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 1
Interventional
Study Start: March 2013
Summary
Principal SponsorLigaChem Biosciences, Inc.
Last updated: November 17, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.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
Principal SponsorLigaChem Biosciences, Inc.
Last updated: November 17, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 20 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
5 inclusion criteria required to participate
Able to donate blood during study period and follow visit
Agree to continue to use a reliable method of birth control until 60 days after study completion
Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
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
Show More Criteria
4 exclusion criteria prevent from participating
History drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc
History of gastrointestinal problem 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 liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalLCB01-0371 800mg
Group II
ExperimentalLCB01-0371 1200mg
Group III
PlaceboPlacebo
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center