NCT02529241终止1 期
An Open-label, Single Dose, Parallel Design, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Oral Dosage Form of LCB01-0371 in Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Pharmacokinetics: Peak Plasma Concentration (Cmax)
研究概览
简要总结
To investigate pharmacokinetics, safety and tolerability of LCB01-0371, LCB01-0371-B after a single oral dose in healthy male subjects.
To investigate safety, tolerability of LCB01-0371 after a single oral dose in healthy male subjects.
详细描述
An Open-label, Single dose, Parallel design, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Oral dosage form of LCB01-0371 in Healthy Male Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male between 20 and 40 years of age at the time of screening
- •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
排除标准
- •History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 6 months 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
- •History of clinically significant disease such as allergic or anaphylactic reaction to drug, cardiovascular, peripheral vascular system, skin, mucous membrane, eye, otorhinolaryngologic system, respiratory, musculoskeletal, infection disease, Gastrointestinal system , liver, biliary system, endocrine, kidney, urogenital system, nervous system, psychiatric system, blood dyscrasia, tumor, fracture, problem(s)
- •blood donation and transfusion within 60 days prior to screening visit
- •Treatment with an other investigational product or Participation in other bioequivalence test within 90 days prior to screening visit
- •Use medication which expected to influence in this study within 30 days prior to screening visit
- •smokers over 10 cigarettes per day within 30 days prior to screening visit or unable to stop smoking in this protocol for the duration of the study from first dose of investigational product
- •drinkers over 3 glasses alcohol drink per week within 30 days prior to screening visit or unable to stop drinking in this protocol for the duration of the study from first dose of investigational product
- •positive result at urine drug screening test or urine nicotine test at screening visit
- •positive result at serum test(hepatitis B, hepatitis C, HIV, syphilis) at screening visit
- •corrected QT interval >450 msec or significant abnormalities on screening ECG
- •other: Patients considered unable perform for the study by the investigator concerning
结局指标
主要结局
Pharmacokinetics: Peak Plasma Concentration (Cmax)
时间窗: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
Pharmacokinetics: time to maximum concentration (Tmax)
时间窗: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)
时间窗: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
次要结局
- Number of Adverse Event(participants will be followed after hospital stay, an expected average of 16 weeks)
研究者
研究点 (2)
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