Safety, Tolerability, PK and PD of SAD or MAD of APX-115 in Healthy Male Volunteers
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Aptabio Therapeutics, Inc.
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 20, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | May 28, 2018 | ||
| 预计主要完成日期 | December 31, 2018 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
SAD study: incidence of treatment emergent adverse events[ Time Frame: Up to Day 8 ] Adverse events will be coded using Meddra. MAD study: incidence of treatment emergent adverse events[ Time Frame: Up to Day 17 ] Adverse events will be coded using Meddra. SAD study: number of clinically significant abnormal findings from biological tests[ Time Frame: Up to Day 8 ] Biological tests include hematology, biochemistry, hemostasis, hormonology, urinalysis, serology, and urine ionogram MAD study: number of clinically significant abnormal findings from biological[ Time Frame: Up to Day 17 ] Biological tests include hematology, biochemistry, hemostasis, hormonology, urinalysis, serology, and urine ionogram SAD study: number of clinically significant abnormal findings from physical exams[ Time Frame: Up to Day 8 ] Physical exams will be performed. MAD part: number of clinically significant abnormal findings from physical exams[ Time Frame: Up to Day 17 ] Physical exams will be performed. SAD study: number of clinically significant abnormal findings from vital sign (blood pressure and heart beat) assessments[ Time Frame: Up to Day 8 ] MAD study: number of clinically significant abnormal findings from vital sign[ Time Frame: Up to Day 17 ] SAD Study: number of clinically significant abnormal findings from concomitant medications[ Time Frame: Up to Day 8 ] MAD Study: number of clinically significant abnormal findings from concomitant medications[ Time Frame: Up to Day 17 ] SAD study: number of clinically significant abnormal findings from electrocardiogram[ Time Frame: Up to Day 8 ] MAD study: number of clinically significant abnormal findings from electrocardiogram[ Time Frame: Up to Day 17 ] Food Effect study: Cmax of APX-115 under fasting and fed conditions[ Time Frame: Up to 48 hours ] Maximum Observed Plasma Concentration of APX-115 will be assessed under fasting and fed conditions. Food Effect study: AUC of APX-115 under fasting and fed conditions[ Time Frame: Up to 48 hours ] Area Under the Plasma Concentration Time Curve of APX-115 will be assessed under fasting and fed conditions. Food Effect study: Tmax of APX-115 under fasting and fed conditions[ Time Frame: Up to 48 hours ] The time at which the Tmax of APX-115 will be assessed under fasting and fed conditions. Food Effect study: half-life of APX-115 under fasting and fed conditions[ Time Frame: Up to 48 hours ] Half-life of APX-115 will be assessed under fasting and fed conditions. Food Effect study: Kel of APX-115 under fasting and fed conditions[ Time Frame: Up to 48 hours ] Elimination rate constant of APX-115 will be assessed under fasting and fed conditions. Drug Interaction Study: Cmax of a metabolic probe with and without APX-115[ Time Frame: Up to 48 hours after administration of metabolic probe ] Maximum Observed Plasma Concentration of a metabolic probe will be assessed with and without a single dose of APX-115. Drug Interaction Study: Incidences of treatment emergent adverse events[ Time Frame: Up to 48 hours after administration of metabolic probe ] Adverse events will be coded using Meddra. Drug Interaction Study: tmax of a metabolic probe with and without APX-115[ Time Frame: Up to 48 hours after administration of metabolic probe ] First time to reach tmax (h) of a metabolic probe with and without a single dose of APX-115. Drug Interaction Study: Kel of a metabolic probe with and without APX-115[ Time Frame: Up to 48 hours after administration of metabolic probe ] Elimination rate constant of a metabolic probe with and without a single dose of APX-115. Drug Interaction Study: t1/2 of a metabolic probe with and without APX-115[ Time Frame: Up to 48 hours after administration of metabolic probe ] Plasma elimination half-life of a metabolic probe will be assessed with and without a single dose of APX-115. Drug Interaction Study: Volume of distribution of a metabolic probe with and without a single dose of APX-115[ Time Frame: Up to 48 hours after administration of metabolic probe ] Volume of distribution of a metabolic probe will be assessed with and without a single dose of APX-115 Drug Interaction Study: Clearance of a metabolic probe with and without a single dose of APX-115[ Time Frame: Up to 48 hours after administration of metabolic probe ] Clearance of a metabolic probe will be assessed with and without a single dose of APX-115. Drug Interaction Study: AUC of a metabolic probe with and without APX-115[ Time Frame: Up to 48 hours after administration of metabolic probe ] Area under the plasma concentration curve of a metabolic probe will be assessed with and without a single dose of APX-115. |
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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 | Safety, Tolerability, PK and PD of SAD or MAD of APX-115 in Healthy Male Volunteers | ||
| 正式标题 ICMJE | Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses or Multiple Ascending Doses of APX-115 in Healthy Male Volunteers. | ||
| 简要概况 | This study aims to evaluate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of single ascending doses and multiple ascending doses of APX-115 in healthy males. This study also aims to evaluate the effect of food consumption on the pharmacokinetics of APX-115 and potential interaction between caffeine and APX-115 in healthy males. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 1 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Parallel design for SAD and MAD studies Crossover design for Food and Drug interaction studies 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 | Recruiting | ||
| 预计入组 ICMJE |
88 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 31, 2018 | ||
| 预计主要完成日期 | December 31, 2018 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion: - Healthy male subject, aged between 18 and 45 years inclusive - Certified as healthy by a comprehensive clinical assessment - Normal dietary habits - Normal ECG recording on a 12-lead ECG - Signing a written informed consent prior to selection Exclusion: - Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious or ocular disease - Frequent headaches and / or migraine, recurrent nausea and / or vomiting - Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position - Blood donation (including in the frame of a clinical trial) within 2 months before administration - General anaesthesia within 3 months before administration - Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician - Inability to abstain from intensive muscular effort - No possibility of contact in case of emergency - Any drug intake (except paracetamol or contraception) during the last month prior to the first administration - History or presence of drug or alcohol abuse (alcohol consumption > 30 grams / day) - Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day) - Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests - Positive results of screening for drugs of abuse - Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development - Administrative or legal supervision | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：45 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | France | ||
| 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: 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 | Aptabio Therapeutics, Inc. | ||
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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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