An Open-label, Single Dose, Parallel Design, Phase 1 Clinical Study of LCB01-0371
2016年4月7日 更新者:LegoChem Biosciences, Inc
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
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.
研究概览
详细说明
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
研究类型
介入性
注册 (实际的)
12
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Seoul、大韩民国
- Asan Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 40年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Group 1: LCB01-0371
Period 1: LCB01-0371 Tablet 400 mg Period 2: LCB01-0371 Tablet 400 mg
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实验性的:Group 2: LCB01-0371
Period 1: LCB01-0371 Tablet 800 mg Period 2: LCB01-0371 Tablet 1200 mg
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Pharmacokinetics: Peak Plasma Concentration (Cmax)
大体时间:0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
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0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
|
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Pharmacokinetics: time to maximum concentration (Tmax)
大体时间:0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
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0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
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Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)
大体时间:0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
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0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
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Number of Adverse Event
大体时间:participants will be followed after hospital stay, an expected average of 16 weeks
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participants will be followed after hospital stay, an expected average of 16 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Kyun-Seop Bae, MD PhD、Asan Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年7月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2015年8月12日
首先提交符合 QC 标准的
2015年8月18日
首次发布 (估计)
2015年8月20日
研究记录更新
最后更新发布 (估计)
2016年4月8日
上次提交的符合 QC 标准的更新
2016年4月7日
最后验证
2016年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.