To Evaluate the Effect of Food on Pharmacokinetics(PK), Phase I Clinical Study of LCB01-0371
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: LCB01-0371 Tablet 800 mg(R)Drug: LCB01-0371 Tablet 800 mg(T)
- Registration Number
- NCT02538003
- Lead Sponsor
- LigaChem Biosciences, Inc.
- Brief Summary
The purpose of this study is to assess safety, tolerability of LCB01-0371 after fasting/non-fasting food taken in healthy male subjects.
- Detailed Description
A Randomized, Open-label, Single dose, Crossover, Phase Ⅰ Trial to evaluate the effect of food on the pharmacokinetics of LCB01-0371 in healthy male subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
- Healthy male between 20 and 40 years of age at the time of screening with body mass index (BMI) between 19 kg/m2 and 28 kg/m2 at the time of screening
- Appropriated for a medical examination by interview,Vital sign,physical examination, local laboratory test result and 12-lead ECG
- Capable of performing follow up visit, blood sampling
- Agree to continue to use a medically reliable dual contraception and not to donate sperm in this protocol for the duration of the study and for 28 days after last dose of investigational product
- Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements
Exclusion Criteria
- History of clinically significant disease such as digestive system, respiratory, musculoskeletal, cardiovascular, endocrine, neuropsychiatry, hematology, cardiovascular system
- History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 180 days possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
- 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(except non active allergic rhinitis)
- History of drug abuse or positive result at urine drug screening test at screening visit
- Intake drug which expected to chronic influence of drug absorption or elimination within 30 days prior to screening visit
- Other: Patients considered unable perform for the study by the investigator concerning
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 1(RT):LCB01-0371 Tablet 800mg LCB01-0371 Tablet 800 mg(R) 1. Period:LCB01-0371 Tablet 800mg(Reference: Taken drug before meal) 2. Period: LCB01-0371 Tablet 800 mg(Test: Taken drug after meal) Group 2(TR):LCB01-0371 Tablet 800mg LCB01-0371 Tablet 800 mg(R) 1. Period:LCB01-0371 Tablet 800mg(Test:taken drug after meal) 2. Period: LCB01-0371 Tablet 800 mg(Reference:taken drug before meal) Group 1(RT):LCB01-0371 Tablet 800mg LCB01-0371 Tablet 800 mg(T) 1. Period:LCB01-0371 Tablet 800mg(Reference: Taken drug before meal) 2. Period: LCB01-0371 Tablet 800 mg(Test: Taken drug after meal) Group 2(TR):LCB01-0371 Tablet 800mg LCB01-0371 Tablet 800 mg(T) 1. Period:LCB01-0371 Tablet 800mg(Test:taken drug after meal) 2. Period: LCB01-0371 Tablet 800 mg(Reference:taken drug before meal)
- Primary Outcome Measures
Name Time Method Number of Adverse events From date of randomization until follow up after 7 days from last hospital discharge
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: AUClast(Area under the plasma concentration) 0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours Pharmacokinetics: Cmax(Peak plasma concentration) 0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Bundang, Gyeonggi, Korea, Republic of