Multiple Ascending Dose Study for LCB01-0371
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|ClinicalTrials.gov Identifier: NCT01842516|
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : November 17, 2014
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- 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
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: LCB01-0371 800mg Drug: LCB01-0371 1200mg Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||December 2013|
Experimental: LCB01-0371 800mg
Drug: LCB01-0371 800mg
Other Name: LCB0-0371 800mg
Experimental: LCB01-0371 1200mg
Drug: LCB01-0371 1200mg
Placebo Comparator: Placebo
- Number of participants with adverse events [ Time Frame: Up to 7 days ]
- Area under the plasma concentration versus time curve (AUC) of LCB01-0371 [ Time Frame: Up to 7 days ]
- Peak Plasma Concentration (Cmax) of LCB01-0371 [ Time Frame: Up to 7 days ]
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|Ages Eligible for Study:||20 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test
- 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.
- History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
- 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 drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842516
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Kyun-Seop Bae, MD, PhD.||Asan Medical Center|
|Responsible Party:||LegoChem Biosciences, Inc|
|Other Study ID Numbers:||
|First Posted:||April 29, 2013 Key Record Dates|
|Last Update Posted:||November 17, 2014|
|Last Verified:||November 2014|
Protein Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action