Drug Penetration Into Bone After Repeated Oral Administration of Debio 1450 to Patients Undergoing Hip Replacement Surgery
2017年10月17日 更新者：Debiopharm International SA
A Phase 1, Open-Label Pharmacokinetic Study to Investigate Drug Penetration in the Bone After Repeated Oral Administration of Debio 1450 to Patients Undergoing Hip Replacement Surgery
Debio 1450 is being developed for the treatment of staph (staphylococcal) infections.
How fast and completely an antibiotic penetrates into bone is used to determine how effective it might be to treat infections related to bones or joints.
Since bone has fewer blood vessels than other tissue (for example lung tissue or the skin), drugs have a harder time getting into them.
It is important to find out how much of the antibiotic can get into the bone to help patients with bone infections.
研究概览
研究类型
介入性
注册 (实际的)
17
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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California
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La Mesa、California、美国、91941
- eStudySite
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Montana
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Butte、Montana、美国、59701
- Mercury St Medical Group, PLLC
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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
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Meets protocol-specified criteria for qualification and contraception
- Is willing and able to comply with restrictions related to food, drink and medications
- Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Exclusion Criteria:
- Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- the safety or well-being of the participant or study staff;
- the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
- the analysis of results
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：Debio 1450
Participants will receive 3 oral administrations of Debio 1450 at a dose of 240 mg approximately 12 hours apart. The last dose should be given approximately 2, 4, 6 or 12 hours prior to surgery with 3 patients each to be dosed at each of these time points. If the surgery is delayed by more than 12 hours postdose, the patients could receive up to 2 additional administrations (approximately 12 hours apart) to ensure that the last dose is administered between 2 and 12 hours before the surgery. |
Debio 1450, 40 mg, powder for oral solution, for reconstitution in 5% dextrose in water.
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无干预：Calibration
A single participant will not receive the study drug, providing data to be used as calibration.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Bone to plasma ratio for Debio 1452 (the Debio 1450 active moiety)
大体时间：at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant
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Bone/bone marrow/soft tissue/synovial fluid samples will be collected during surgery; time of resection will be used to calculate the elapsed time after last dosing.
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at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Plasma ratios for Debio 1452
大体时间：at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant
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Categories: Bone marrow:plasma; soft tissue:plasma; synovial fluid:plasma
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at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant
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Area under the curve at steady state (AUCτ) of Debio 1452
大体时间：at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant
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at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant
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Maximum observed plasma concentration (Cmax) of Debio 1452
大体时间：at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant
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at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant
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Measured concentration at the end of a dosing interval at steady state (Ctrough) of Debio 1452
大体时间：at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant
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at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2016年4月1日
初级完成 (实际的)
2017年6月1日
研究完成 (实际的)
2017年6月1日
研究注册日期
首次提交
2016年3月29日
首先提交符合 QC 标准的
2016年3月29日
首次发布 (估计)
2016年4月1日
研究记录更新
最后更新发布 (实际的)
2017年10月18日
上次提交的符合 QC 标准的更新
2017年10月17日
最后验证
2017年10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.
Debio 1450的临床试验
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate...Merck KGaA, Darmstadt, Germany完全的
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EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, Germany招聘中头颈癌美国, 中国, 比利时, 台湾, 大韩民国, 日本, 以色列, 巴西, 希腊, 墨西哥, 英国, 阿根廷, 奥地利, 捷克语, 法国, 乔治亚州, 德国, 印度, 意大利, 罗马尼亚, 西班牙, 瑞士, 荷兰, 波兰, 葡萄牙
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EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, Germany; GORTEC (Head and Neck Oncology and Radiotherapy Group)主动，不招人头颈部鳞状细胞癌美国, 西班牙, 大韩民国, 台湾, 中国, 阿根廷, 法国, 日本, 以色列, 英国, 比利时, 德国, 葡萄牙, 希腊, 意大利, 乔治亚州, 澳大利亚, 捷克语, 巴西, 加拿大, 奥地利, 俄罗斯联邦, 瑞士, 匈牙利, 波兰, 乌克兰