Phase I Study in Healthy Male Subjects Comparing QGC001 to Placebo
2013年7月11日 更新者:Quantum Genomics SA
A Phase I, Double-blind, Placebo-controlled, Ascending Single-dose, Safety, Tolerability and Pharmacokinetic Study of QGC001 in Healthy Male Subjects.
QGC001/1QG1 is a Phase I "first time in man" study aiming to determine the overall safety and tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system, blood pressure and heart rate) in healthy male subjects.
研究概览
研究类型
介入性
注册 (实际的)
56
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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Rueil-Malmaison、法国、92502
- Biotrial PARIS
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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 45年 (成人)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Caucasian, male healthy subjects of 18 to 45 years of age.
- Body weight ≥50 kg, with a body mass index calculated as weight in kg/(height in m2) from 18 to 27 kg/m2 at screening.
- Subjects will sign and date an informed consent form before any study-specific screening procedure is performed.
- Healthy, as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings.
- Non-smoker or smoker of fewer than 5 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
- Have a high probability for compliance with and completion of the study.
Exclusion Criteria:
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatological, haematological, neurologic, psychiatric disease or history of any clinically important drug allergy.
- Acute disease state within 7 days before study day 1.
- History of drug abuse within 1 year before study day 1.
- History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day.
- Positive serologic findings for human immunodeficiency virus antibodies, hepatitis B surface antigen, and/or hepatitis C virus antibodies.
- Positive findings of urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA)
- History of any clinically important drug allergy.
- Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product administration.
- Consumption of any caffeine-containing products in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
- Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before investigational medicinal product administration.
- Donation of blood (i.e. 450 ml) within 90 days before study day 1.
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
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:10 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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实验性的:50 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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实验性的:125 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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实验性的:250 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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实验性的:500 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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实验性的:750 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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实验性的:1,000 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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实验性的:1,250 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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安慰剂比较:Placebo
The placebo was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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含有硬脂酸镁、牙科用二氧化硅、无水乳糖
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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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Adverse events
大体时间:up to 11 days
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up to 11 days
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Blood pressure
大体时间:up to 11 days
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up to 11 days
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Heart rate
大体时间:up to 11 days
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up to 11 days
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Body temperature
大体时间:up to 11 days
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up to 11 days
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12-lead ECG
大体时间:up to 11 days
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up to 11 days
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Red blood cell count
大体时间:up to 11 days
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up to 11 days
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Haemoglobin
大体时间:up to 11 days
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up to 11 days
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Haematocrit
大体时间:up to 11 days
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up to 11 days
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White blood cell count with differential
大体时间:up to 11 days
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up to 11 days
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Platelet count
大体时间:up to 11 days
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up to 11 days
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Plasma sodium
大体时间:up to 11 days
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up to 11 days
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Plasma potassium
大体时间:up to 11 days
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up to 11 days
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Plasma calcium
大体时间:up to 11 days
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up to 11 days
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Plasma total bilirubin
大体时间:up to 11 days
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up to 11 days
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Plasma conjugated bilirubin
大体时间:up to 11 days
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up to 11 days
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Plasma Aspartate Amino Transferase (ASAT)
大体时间:up to 11 days
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up to 11 days
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Plasma Alanine Amino Transferase (ALAT)
大体时间:up to 11 days
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up to 11 days
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Plasma Gamma Glutamyl Transferase (GGT)
大体时间:up to 11 days
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up to 11 days
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Plasma alkaline phosphatases
大体时间:up to 11 days
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up to 11 days
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Plasma total protein
大体时间:up to 11 days
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up to 11 days
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Plasma Creatine PhosphoKinase (CPK)
大体时间:up to 11 days
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up to 11 days
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Plasma creatinine
大体时间:up to 11 days
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up to 11 days
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Plasma glucose
大体时间:up to 11 days
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up to 11 days
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Plasma cholesterol
大体时间:up to 11 days
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up to 11 days
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Plasma triglycerides
大体时间:up to 11 days
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up to 11 days
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Urinary pH
大体时间:up to 11 days
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up to 11 days
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Urinary protein
大体时间:up to 11 days
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up to 11 days
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Urinary glucose
大体时间:up to 11 days
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up to 11 days
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Urinary leukocytes
大体时间:up to 11 days
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up to 11 days
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Urinary nitrites
大体时间:up to 11 days
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up to 11 days
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Urinary ketones
大体时间:up to 11 days
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up to 11 days
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Urinary blood
大体时间:up to 11 days
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up to 11 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Maximum observed plasma concentration (Cmax) of QGC001
大体时间:H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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Time at which Cmax is observed (tmax) of QGC001
大体时间:H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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Elimination rate constant (λz) of QGC001
大体时间:H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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Terminal half-life (t1/2,z) of QGC001
大体时间:H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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Area Under the Concentration-time curve (AUClast and AUC0-∞) of QGC001
大体时间:H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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Maximum observed plasma concentration (MRCmax) of metabolic ratios
大体时间:H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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Area Under the Concentration-time curve (MRAUC) of metabolic ratios
大体时间:H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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Cumulative amount eliminated (Ae)
大体时间:H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
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H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
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Fraction recovered (Fe)
大体时间:H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
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H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
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Renal clearance (CLR)
大体时间:H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
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H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
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Plasma renin
大体时间:H-1 pre-dose and H2, H4 and H9 post-dose
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Determination of renin in blood samples.
In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
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H-1 pre-dose and H2, H4 and H9 post-dose
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Plasma aldosterone
大体时间:H-1 pre-dose and H2, H4 and H9 post-dose
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Determination of aldosterone in blood samples.
In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
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H-1 pre-dose and H2, H4 and H9 post-dose
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Plasma cortisol
大体时间:H-1 pre-dose and H2, H4 and H9 post-dose
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Determination of cortisol in blood samples.
In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
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H-1 pre-dose and H2, H4 and H9 post-dose
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Plasma copeptin
大体时间:H-1 pre-dose and H2, H4 and H9 post-dose
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Determination of copeptin in blood samples (if possible, will be determined later).
In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
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H-1 pre-dose and H2, H4 and H9 post-dose
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Urinary aldosterone
大体时间:H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
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Aldosterone analysis in urine samples.
In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
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H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
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Urinary cortisol
大体时间:H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
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Cortisol analysis in urine samples.
In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
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H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
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Urinary creatinin
大体时间:H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
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Creatinin analysis in urine samples.
In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
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H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
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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
2012年2月1日
初级完成 (实际的)
2012年5月1日
研究完成 (实际的)
2012年5月1日
研究注册日期
首次提交
2013年6月26日
首先提交符合 QC 标准的
2013年7月11日
首次发布 (估计)
2013年7月16日
研究记录更新
最后更新发布 (估计)
2013年7月16日
上次提交的符合 QC 标准的更新
2013年7月11日
最后验证
2013年7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.
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