A Phase 1 Safety and PK Study of IV Eravacycline
赞助:
Tetraphase Pharmaceuticals, Inc.
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 26, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | December 13, 2018 | ||
| 预计主要完成日期 | June 27, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Assess the Pharmacokinetics (PK) parameters for Cmax, maximum observed plasma concentration[ Time Frame: Screening (-2 to 1) to Day 7 ] Cmax, maximum observed plasma concentration Assess the Pharmacokinetics (PK) parameters for AUC0-t, area under the plasma concentration-time curve[ Time Frame: Screening (-2 to 1) to Day 7 ] AUC0-t, area under the plasma concentration Assess the Pharmacokinetics (PK) parameters for AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time[ Time Frame: Screening (-2 to 1) to Day 7 ] AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time Assess the Pharmacokinetics (PK) parameters for AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose[ Time Frame: Screening (-2 to 1) to Day 7 ] AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose Assess the Pharmacokinetics (PK) parameters for t1/2, elimination half-life[ Time Frame: Screening (-2 to 1) to Day 7 ] t1/2, elimination half-life Assess the Pharmacokinetics (PK) parameters for Clast,, last observed plasma concentration[ Time Frame: Screening (-2 to 1) to Day 7 ] Clast, last observed plasma concentration Assess the Pharmacokinetics (PK) parameters for CL, systemic clearance[ Time Frame: Screening (-2 to 1) to Day 7 ] CL, systemic clearance Assess the Pharmacokinetics (PK) parameters for Vd, volume of distribution[ Time Frame: Screening (-2 to 1) to Day 7 ] Vd, volume of distribution |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | A Phase 1 Safety and PK Study of IV Eravacycline | ||
| 正式标题 ICMJE | A Phase 1, Open-label, Multicenter Study to Determine the Pharmacokinetics and Safety of Intravenous Eravacycline in Children With Suspected or Confirmed Bacterial Infection | ||
| 简要概况 | This is a Phase 1, open-label, multi-center study to determine the pharmacokinetics and safety of intravenous Eravacycline in Children with Suspected or Confirmed Bacterial Infection. Male and Female subjects from 8 to <18 years of age who fulfill the inclusion/exclusion criteria will be enrolled in this study. |
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| 详细说明 | This is a Phase 1, open-label, single dose study to evaluate PK, safety, and tolerability of IV eravacycline in children with suspected or confirmed bacterial infection who are receiving systemic antibiotic therapy, other than eravacycline. The study design will allow for evaluation of PK and safety of IV eravacycline in a pediatric population at exposures predicted to be comparable to those already studied in adults. The study design is depicted in Figure 1. Two cohorts defined by age group will be enrolled simultaneously: - Cohort 1: 12 to <18 years of age (adolescents) - Cohort 2: 8 to <12 years of age (younger children) Eravacycline will be administered as a single IV dose using the optimum dosage determined from PK-PD modeling and model-based simulations of phase 1, 2, and 3 adult data. Blood samples will be collected for PK analysis at predetermined timepoints. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 1 | ||
| 研究设计 ICMJE | 分配: Non-Randomized 干预模型: Parallel Assignment 干预模型描述: Single Group Assignment 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
20 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | October 17, 2019 | ||
| 预计主要完成日期 | June 27, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Male or female from 8 to <18 years of age on the day informed consent (and assent, if applicable) is obtained 2. Written informed consent from parent(s) or other legally authorized representative(s) and informed assent from subject (if age appropriate according to local requirements) 3. Hospitalized, in stable condition, and receiving or plan to receive within 24 hours systemic antibiotic therapy, other than eravacycline, for a suspected or confirmed bacterial infection 4. Likely to survive the current illness 5. In the Investigator's opinion, the subject will require hospitalization for at least 24 hours following administration of the study drug 6. The subject appears to have sufficient intravascular access (peripheral or central) to receive study drug Exclusion Criteria: 1. Male or female from 8 to <18 years of age on the day informed consent (and assent, if applicable) is obtained 2. Written informed consent from parent(s) or other legally authorized representative(s) and informed assent from subject (if age appropriate according to local requirements) 3. Hospitalized, in stable condition, and receiving or plan to receive within 24 hours systemic antibiotic therapy, other than eravacycline, for a suspected or confirmed bacterial infection 4. Likely to survive the current illness 5. In the Investigator's opinion, the subject will require hospitalization for at least 24 hours following administration of the study drug 6. The subject appears to have sufficient intravascular access (peripheral or central) to receive study drug 7. Subject is a child of an employee of the Investigator or study center who has direct involvement in the proposed study or other studies under the direction of the same Investigator or study center, or an immediate family member of the employee or the Investigator, defined as a spouse, parent, child, or sibling, whether biological or legally adopted 8. Breastfeeding females 9. Females of childbearing potential [those with menarche and/or thelarche (beginning of breast development)] and sexually active males who are unwilling or unable to use an acceptable method of contraception 10. Positive pregnancy test in females of childbearing potential 11. Any other circumstance that, in the opinion of the Investigator, would preclude subject participation in the study | ||
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| 年龄 | 最小年龄：8 Years ，最大年龄：17 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Tetraphase Pharmaceuticals, Inc. | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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