NCT00622115已完成1 期
A Phase I, Pharmacokinetic and Tolerability Study of Intravenous Unfractionated Heparin After Subcutaneous Enoxaparin 1mg/kg Bid Repeated Administration in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Concentration-time profiles of anti-Xa and anti-IIa levels
研究概览
简要总结
Primary objective:
- to characterize the pharmacokinetic and the pharmacodynamic profile after intravenous bolus injection of unfractionated heparin (UFH) after repeated sc 100 IU anti-Xa/kg (corresponding to 1 mg/kg) twice a day during 2.5 days (every 12±2hrs) administrations of enoxaparin in Caucasian healthy subjects.
Secondary objective(s):
- to compare the pharmacokinetic and the pharmacodynamic profile between 3 different timing of administration of the UFH
- to assess the tolerability of the different anticoagulation protocols
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian
- •Male and female subjects, between 40 and 60 years of age
- •Body weight between 50 kg and 90 kg if male and between 40 and 80 kg if female with Body Mass Index (BMI) between 18 and 29 kg/m2
- •Health Status:
- •Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)
- •Subject with hypertension, hypo- or hyperthyroidism or dyslipidemia will be included if their concomitant pathology is well-controlled by treatment for at least one year
- •Normal vital signs after 10 minutes resting in supine position:
- •95 mmHg < systolic blood pressure (SBP) < 140 mmHg;
- •45 mmHg < diastolic blood pressure (DBP) < 90 mmHg;
- •40 bpm < heart rate < 100 bpm.
- •Normal 12-lead electrocardiogram (ECG); 120 ms < PR < 220 ms, QRS < 120 ms, QTc ≤ 430 ms for male, 450 ms for female or not considered as clinically significant by the investigator
- •Laboratory parameters within the normal range unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; hepatic enzymes (aspartate amino-transferase or AST, alanine amino-transferase or ALT) should be strictly below the upper laboratory norm.
- •Platelets ≥ 150 000 / mm3
- •Mean corpuscular volume (MCV) and gamma glutamyl-transferase (GGT) should be strictly in the normal range of the laboratory
- •Activated partial thromboplastin time (aPTT) ratio should be comprised between 0.95 and 1.15
- •Estimated Creatinine clearance by Cockroft formula should be higher than 50 mL/min
- •Non smoker or smoking the equivalent or less than 5 cigarettes a day and able not to smoke during the study hospitalization
- •Normal gynecological examination no longer than 12 months before inclusion.
- •For female with childbearing potential using an effective contraception method (e.g. intra-uterine device, hormonal contraception, diaphragm and condom) except if postmenopausal for more than 12 months or sterilized for more than three months
- •Subject with coagulation test and blood count (including platelets) within the physiological ranges)
- •Regulations:
- •Having given written informed consent prior to any procedure related to the study
- •Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research
- •Not under any administrative or legal supervision
排除标准
- •Medical history and clinical status:
- •Contra-indication to anticoagulant therapy
- •Subject with known increased bleeding time, hemophilia, thrombocytopenia, and/or history of any vascular purpura
- •Subject with detectable antibody against heparin in the blood
- •Any history or presence of clinically relevant cardiovascular, gynecologic (for women), pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, ocular or infectious disease that is capable of altering the absorption, metabolism, or elimination of drugs, or of constituting a risk factor when taking the study medication; any acute infectious disease or signs of acute illness; except subject with hypertension, hypo- or hyperthyroidism or dyslipidemia if well-controlled by treatment for at least one year.
- •Subject with diabetes or other cardiovascular or metabolic disease
- •Subject with INR > 1.5
- •Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month)
- •Blood donation or blood loss within one month before administration
- •Symptomatic hypotension whatever the decrease in blood pressure or asymptomatic postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position
- •Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician
- •History or presence of drug or alcohol abuse (alcohol consumption > 40 grams/day)
- •Smoking more than 5 cigarettes or equivalent/day, or unable to stop smoking during the study
- •Excessive consumption of beverages with xanthine bases (> 4 cups or glasses/day)
- •Pregnancy (defined as positive beta-HCG plasma test that can not be explicated by menopauses), breast-feeding for female, any history or presence of clinically relevant gynecologic disease
- •Interfering substance:
- •Any medication (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, except for hormonal contraception or replacement therapy, and allowed therapy for stable pathology
- •Anti-inflammatory treatments and anti-aggregant treatments are strictly forbidden during the whole study period
- •General conditions:
- •Subject who, in the judgment of the Investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development
- •Subject in exclusion period of a previous study according to applicable regulations
- •Subject who cannot be contacted in case of emergency
- •Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol or any other protocol of the Investigating Center
- •Subject is an employee of the Investigating Center
- •Biological status:
- •Positive reaction to any of the following tests: HBs antigen, anti-HCV antibodies, anti-HIV1 antibodies, anti-HIV2 antibodies, anti-LMWH antibodies
- •Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids)
- •Positive alcohol breath or plasma test
研究组 & 干预措施
A
Experimental
70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 4 hours following the last injection of enoxaparin
干预措施: Enoxaparin (Drug)
B
Experimental
70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 6 hours following the last injection of enoxaparin
干预措施: Enoxaparin (Drug)
C
Experimental
70 U/kg of UnFractionated Heparin (UFH) administered intravenously at 10 hours following the last injection of enoxaparin
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Concentration-time profiles of anti-Xa and anti-IIa levels
时间窗: At baseline (Day 2) after the morning enoxaparin injection and at day 3 from pre-dose of enoxaparin and lasting until 14 hours after the enoxaparin injection.
次要结局
- Effect-time profiles of ACT, TGTppp and TGTprp(At baseline (Day 2) after the morning enoxaparin sc injection and at day 3 from pre-dose of enoxaparin and lasting until 14 hours after the enoxaparin injection.)
- PFA100 levels measured(At pre-dose, 4h and 14h post dose of enoxaparin)
- Documentation of adverse event, physical examination, clinical laboratory safety, vital signs and ECG recording at prespecified time-points.(during the entire study)
研究者
研究点 (1)
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