EUCTR2008-003774-17-GB进行中（未招募）不适用
A double-blind, placebo-controlled dose response study to investigate pharmacodynamics and pharmacokinetics of single and repeated oral doses of VA106483 in elderly male subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Vantia Ltd
- 入组人数
- 27
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
- Male
入选标准
- •1.Age:65 years and above
- •2.Gender:Male
- •3.Weight: 55–95 kg
- •4.BMI:18–32 kg/m2
- •5.Medical history without clinically relevant pathologies
- •6.A history of nocturia
- •7.Physical examination parameters without signs of serious disease
- •8.Electrocardiogram recording without signs of clinically relevant pathology, in particular QTc (Bazett) <450 ms
- •9.Values for haematology and for biochemistry tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the medical investigator (in particular serum electrolytes)
- •10.Having given written informed consent before any study-related activities are carried out
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •2.Males aged under 65 years
- •3.Evidence of serious pathology or disease
- •4.Cardiac insufficiency; signs or symptoms suggestive of heart failure or requiring treatment with diuretics
- •5.Supine arterial blood pressure higher than 170/100 mmHg or less than 105/60 mmHg
- •6.Presence of poorly controlled endocrine disorders
- •7.Renal insufficiency. Subjects with impaired renal function defined as calculated creatinine clearance < 40 mL/min based upon the value derived at screening using the Cockcroft and Gault equation ((140-age)*(weight in kg)/(72*serum creatinine in mg/dl).
- •8.Active hepatic and/or biliary disease. AST or ALT should not be >10% above maximum of normal range. Total bilirubin should not be > 1.5 mg/dl (or equivalent).
- •9.Hyponatraemia. Plasma sodium level must be within normal limits
- •10.Syndrome of Inappropriate ADH secretion
- •11.Symptoms suggestive of psychogenic or habitual polydipsia or of diabetes insipidus
- •12.Mental handicap
- •13.Legal incapacity
- •14.Any history of clinically important emotional and/or psychiatric illness or of any clinically important neurological disorders and/or epilepsy
- •15.Chronic diarrhoea or other chronic gastrointestinal disorders
- •16.Known hypersensitivity to the study drug or constituent of the study drug
- •17.History of any relevant allergy, especially drug and/or food allergies
- •18.Strict vegetarian
- •19.Intake of diuretics
- •20.Intake of non-prescription medication or vitamin preparations within 14 days of drug administration
- •21.Use of St. John’s Wort or Ginkgo Biloba (also known as Ginkgo Bilbao) within 48 hours prior to randomization
- •22.Participation in a clinical study within 30 days prior to randomization
- •23.Donation of blood within 60 days prior to randomization
- •24.Receipt of blood, blood products or plasma derivates one year prior to randomization
- •25.Any history of alcohol abuse or drug addiction
- •26.Positive results at screen for drugs of abuse (cocaine, amphetamine / methamphetamine, tetrahydrocannabiol, opiates) or alcohol (breath test) at screening or on admission
- •27.Positive screen results for HBsAg, anti-HCV, or anti-HIV1&2
- •28.Any disease which in the Investigator’s opinion would exclude the subject from the study
- •29.Intake of any concomitant medication known to be a cytochrome 3A4 substrate or inhibitor with the exception of simvastatin, atorvastatin, lovastatin and cerivastatin*
- •*The statins listed above are amongst the most common concomitant medications in the population under study. The highest exposure to VA106483 in the current study is Cmax of 71.1ng/ml at a dose of 4mg. Since the Ki of VA106483 for cytochrome P450 3A4 is 7500ng/ml the [I]/Ki is <0.01 rendering any interaction with other 3A4 substrates remote even at doses of VA106483 up to 16mg. Similarly, since the listed statins are also substrates, any effect on the pharmacokinetics of VA106483 is remote
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