Phase 1, Safety and Bronchopulmonary PK Study in Healthy Volunteers
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 27, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | November 2018 | ||
| 预计主要完成日期 | March 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 |
Concentrations of TP-6076 in plasma[ Time Frame: Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4. ] Pharmacokinetics Concentrations of TP-6076 in epithelial lining fluid (ELF)[ Time Frame: Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4. ] Concentrations of TP-6076 in alveolar macrophages (AMs)[ Time Frame: Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4. ] maximum observed concentration (Cmax)[ Time Frame: Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4. ] time to maximum observed concentration (Tmax)[ Time Frame: Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4. ] |
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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 | Phase 1, Safety and Bronchopulmonary PK Study in Healthy Volunteers | ||
| 正式标题 ICMJE | A Phase 1, Open-label, Randomized, PK and Safety Study To Assess Bronchopulmonary Disposition of Intravenous TP-6076 in Healthy Men and Women | ||
| 简要概况 | This is a Phase 1, open-label, randomized, PK and safety study in a maximum of 25 healthy subjects who have provided a bronchoalveolar lavage (BAL) sample. |
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| 详细说明 | This is a Phase 1, open-label, randomized, PK and safety study in a maximum of 25 healthy subjects who have provided a bronchoalveolar lavage (BAL) sample. The dose planned to be administered in this study is an iv infusion of 30 mg TP 6076 q24h for 4 consecutive days (starting on Day 1 and ending on Day 4). Subjects will be randomized to undergo a BAL at a single time point: either 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4. The BAL will be conducted in 5 different subjects at each of the 4 time points, adding up to a total of 20 subjects. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 1 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Basic Science |
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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 | May 2019 | ||
| 预计主要完成日期 | March 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - The following inclusion criteria must be met for a subject to be eligible for inclusion in the study: 1. Status : Healthy subject 2. Gender : Male or female 3. Age : 18 to 50 years, inclusive, at screening 4. Body mass index (BMI) : 18.0 to 30.0 kg/m2, inclusive, at screening 5. Weight : 50 to 105 kg, inclusive, at screening 6. At screening, females must be non-pregnant and non-lactating, or of non childbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year post menopausal [amenorrhoea duration of 12 consecutive months]); non-pregnancy will be confirmed for all females by a serum pregnancy test conducted at screening, admission to the CPU, and follow up. 7. Post-menopausal females using hormone replacement therapy should be on a stable regimen and be using this since at least 3 months prior to the first study drug administration. 8. Female subjects of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception from screening until 90 days after the follow up visit. Adequate contraception will be methods with low user dependency (ie, implanted hormonal contraception, an intrauterine device, an intrauterine hormone releasing system, bilateral tubal occlusion, and/or a sole vasectomised male partner with medical assessment). Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable. 9. Male subjects, if not surgically sterilized, must agree to use adequate contraception when engaging in sexual activity with a female of childbearing potential and not to donate sperm from admission to the CPU until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner) will be methods with low user dependency (ie, implanted hormonal contraception, an intrauterine device, an intrauterine hormone releasing system, bilateral tubal occlusion, and/or a sole vasectomised male subject with medical assessment). Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable. 10. All prescribed medication must have been stopped at least 30 days prior to admission to the CPU. An exception is made for hormonal contraceptives and a stable regimen of hormone replacement therapy, which may be used throughout the study. 11. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the CPU. An exception is made for paracetamol, which is allowed up to admission to the CPU. 12. Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 48 hours prior to admission to the CPU. 13. Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator. 14. Willing to comply with the study procedures. 15. Willing and able to sign the ICF. Exclusion Criteria: A subject who meets any of the following exclusion criteria will not be eligible for inclusion in the study: 1. Previous participation in the current study. 2. Employee of PRA Health Sciences (PRA), Hammersmith Medicines Research Ltd. (HMR), or Tetraphase Pharmaceuticals, Inc. 3. Subjects who may not tolerate a BAL, or cannot undergo a BAL due to the presence of contraindications to a BAL (including abnormal blood coagulation parameters, refractory hypoxemia, reactive airway disease or asthma, unstable angina or acute myocardial infarction in the 6 months prior to the first study drug administration). 4. History of any relevant lung disease. 5. History of relevant drug (including tetracycline-class antibiotics) and/or food allergies. 6. Using tobacco products or electronic cigarettes within 6 months prior to the first study drug administration. 7. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 2 years prior to the first study drug administration. 8. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, cotinine, and alcohol) at screening and admission to the CPU. 9. Average intake of more than 24 units of alcohol per week: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits). 10. Positive screen for hepatitis B surface antigen (HBsAg), antihepatitis C virus (HCV) antibodies, or antihuman immunodeficiency virus (HIV) 1 and 2 antibodies. 11. Participation in a drug study within 60 days prior to the first study drug administration in the current study. Participation in more than 3 other drug studies in the 10 months prior to the first study drug administration in the current study. 12. Donation or loss of more than 400 mL of blood within 90 days prior to the first study drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects)/more than 1.0 liters of blood (for female subjects) in the 10 months prior to the first study drug administration in the current study. 13. Significant and/or acute illness within 5 days prior to the first study drug administration that may impact safety assessments, in the opinion of the Investigator. 14. Unsuitable veins for infusion or blood sampling. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：50 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 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 | September 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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