Clinical trial NCT01842516: Multiple Ascending Dose Study for LCB01-0371
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LigaChem Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary

* 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

Detailed description: * 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

Eligibility criteria: Inclusion Criteria:

1. 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
2. Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test
3. Able to donate blood during study period and follow visit.
4. Agree to continue to use a reliable method of birth control until 60 days after study completion.
5. Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion Criteria:

1. History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
2. History of gastrointestinal problem which is affect to absorption within 6 months from screening
3. 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.
4. History drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 7 days
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of LCB01-0371
timeFrame: Up to 7 days
measure: Peak Plasma Concentration (Cmax) of LCB01-0371
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho YS, Lim HS, Cho YL, Nam HS, Bae KS. Multiple-dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral LCB01-0371 in Healthy Male Volunteers. Clin Ther. 2018 Dec;40(12):2050-2064. doi: 10.1016/j.clinthera.2018.10.007. Epub 2018 Nov 10.