Clinical trial NCT02538003: To Evaluate the Effect of Food on Pharmacokinetics(PK), Phase I Clinical Study of LCB01-0371
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LigaChem Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-02
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Appropriated for a medical examination by interview,Vital sign,physical examination, local laboratory test result and 12-lead ECG
3. Capable of performing follow up visit, blood sampling
4. 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
5. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

Exclusion Criteria:

1. History of clinically significant disease such as digestive system, respiratory, musculoskeletal, cardiovascular, endocrine, neuropsychiatry, hematology, cardiovascular system
2. 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)
3. 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)
4. History of drug abuse or positive result at urine drug screening test at screening visit
5. Intake drug which expected to chronic influence of drug absorption or elimination within 30 days prior to screening visit
6. Other: Patients considered unable perform for the study by the investigator concerning

Primary outcomes:
measure: Number of Adverse events
timeFrame: From date of randomization until follow up after 7 days from last hospital discharge
Secondary outcomes:
measure: Pharmacokinetics: AUClast(Area under the plasma concentration)
timeFrame: 0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours
measure: Pharmacokinetics: Cmax(Peak plasma concentration)
timeFrame: 0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours
Other outcomes:
Locations:
city: Bundang
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jaeyong Chung, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: