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临床试验/EUCTR2010-020343-13-GB
EUCTR2010-020343-13-GB进行中（未招募）不适用

A double-blind, randomised, placebo-controlled, 4-way cross-over Phase I study to investigate the pharmacokinetics, pharmacodynamics and safety of escalating single doses of E-52862 in young healthy male and female subjects

aboratorios del Dr Esteve S.A0 个研究点开始时间: 2010年6月11日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1. Healthy male or female subjects aged between 18 and 35 years (inclusive) at
  • •2. Signed informed consent in the local language prior to any study-mandated procedure.
  • •3. No clinically significant findings on the physical examination at screening and at
  • •admission on Day -2 of Period 1.
  • •4. Body mass index (BMI) between 18 and 25 kg/m2 (inclusive) at screening and at
  • •admission on Day -2 of Period 1, body weight at least 45 kg.
  • •5. Systolic blood pressure 100–130 mmHg, diastolic blood pressure 60–80 mmHg, and
  • •pulse rate 40–90 bpm (all inclusive), measured on the left arm, after 10 minutes in the
  • •supine position at screening and at admission on Day -2 of Period 1.
  • •6. Triplicate 12-lead ECG without clinically relevant abnormalities measured after 10
  • •minutes in the supine position at screening and at admission on Day -2 of Period 1.
  • •7. 24-hour 5-lead Holter ECG without clinically relevant abnormalities measured at
  • •8. Haematology, biochemistry, and urinalysis test results not deviating from the normal
  • •range to a clinically relevant extent at screening and at admission on Day -2 of Period
  • •9. The Caucasian subjects should be distinguished especially by very light to brown skin
  • •pigmentation and straight to wavy or curly hair, and should be indigenous to Europe,
  • •northern Africa, western Asia, and India. Therefore, the study may as well include
  • •Caucasian subjects from North America, Australia and South Africa.
  • •10. Subjects must agree to use acceptable methods of contraception
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •1. History or clinical evidence of any disease and/or existence of any surgical or medical
  • •condition which might interfere with the absorption, distribution, metabolism or
  • •excretion of the study drug (appendectomy and herniotomy allowed, cholecystectomy
  • •not allowed).
  • •2. History of clinically significant syncope.
  • •3. Family history of sudden death.
  • •4. Family history of premature cardiovascular death.
  • •5. Clinically significant history or family history of congenital long QT syndrome (e.g.
  • •Romano-Ward syndrome, Jervell and Lange-Nielson syndrome) or Brugada's
  • •6. History of clinically significant arrhythmias and ischemic heart disease (especially
  • •ventricular arrhythmias, atrial fibrillation, recent conversion from atrial fibrillation or
  • •coronary spasm).
  • •7. Conditions predisposing the volunteer to electrolyte imbalances (e.g. altered nutritional
  • •states, chronic vomiting, anorexia nervosa, bulimia nervosa).
  • •8.ECG abnormalities in the standard 12-lead ECG (at screening and Day -2 of Period 1) and 24-hour 5-lead Holter ECG (at screening) which in the opinion of the Investigator will interfere with the ECG analysis.
  • •9. Any clinically important abnormalities in rhythm, conduction or morphology of resting
  • •ECG that may interfere with the interpretation of QTc interval changes. This includes
  • •subjects with any of the following (at screening and Day -2 of Period 1):
  • •Sinus node dysfunction.
  • •Clinically significant PR (PQ) interval prolongation.
  • •Intermittent second or third degree AV block.
  • •Incomplete or complete bundle branch block.
  • •Abnormal T-wave morphology.
  • •Prolonged QTcB >450 msec or shortened QTcB <350 msec or family history of
  • •long QT syndrome.
  • •Subject with borderline deviations from these criteria may be included if the deviations do not pose a safety risk, and if agreed between the appointed Cardiologist and the Principal Investigator.
  • •10. Signs and/or symptoms of a clinically relevant acute illness in the 4-week period prior to screening.
  • •11. Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture).
  • •12. Known hypersensitivity to any medicines administered in the trial.
  • •13. Treatment with any prescribed medication during the two weeks prior to first baseline day.
  • •14. Treatment with any over-the-counter (OTC) medications during the two weeks prior to first baseline day.
  • •15. Treatment with vitamins and/or minerals within 48 hours prior to the first baseline day.
  • •16. Treatment with another investigational drug within three months prior to dosing or having participated in more than three investigational drug studies within 1 year prior to dosing.
  • •17. Confirmed positive results from urine drug screen (amphetamines, benzodia
  • •cocaine, cannabinoids, opiates, barbiturates and methadone) or from the alcohol
  • •breath test at screening and on Day -2 of Period 1.
  • •18. History or clinical evidence of alcoholism or drug abuse. Alcohol abuse is defined as regular weekly intake of more than 14 units if female and 21 units if male; drug abuse is defined as compulsive, repetitive and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms.
  • •19. Excessive caffeine consumption, defined as = 800 mg per day at screening (800 mg = 7 cups of coffee or 16 cups of tea).
  • •20. Chronic use o

研究者

发起方
aboratorios del Dr Esteve S.A

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