EUCTR2018-001071-20-ES进行中（未招募）1 期
A 10-day prospective, single-center, double-blind, placebo-controlled, randomized study to evaluate safety, tolerability and pharmacokinetics of 600 mg b.i.d. oral doses of LM11A-31-BHS in healthy elderly volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
入选标准
- •1.Men and women (non-childbearing potential)
- •2.Age 60-85 years
- •3.Formal education for eight or more years
- •4.Volunteers living at home or nursing home setting without continuous nursing care
- •5.General health status acceptable for a participation in a 10-day clinical trial
- •6.Stable pharmacological treatment of any other chronic condition for at least one month prior to screening
- •7.No regular intake of prohibited medications as noted in Section 6.8.
- •8.Signed informed consent by volunteer prior to the initiation of any study specific procedure
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Failure to perform screening or baseline examinations
- •2.Hospitalization or change of chronic concomitant medication one month prior to screening or during screening period
- •3.A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder
- •4.Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, and which may bias the assessment of the clinical or mental status of the volunteer or put the volunteer at special risk, such as:
- •chronic liver disease, liver function test abnormalities or other signs of hepatic insufficiency (ALT, AST, Gamma GT, alkaline phosphatase > 2.5 ULN)
- •Respiratory insufficiency
- •Renal insufficiency (serum creatinine > 2mg/dL) or creatinine clearance = 30 mL/min according to Cockcroft-Gault formula). In case of creatinine clearance = 30mL/min, an alternative verification of the renal function must be completed using Cystatin C analysis. In case of normal level of Cystatin C, the volunteer can be included.
- •Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within six months before screening)
- •Bradycardia (heart beat < 50/min.) or tachycardia (heart beat > 95/min.)
- •Hypertension (<180/95) or hypotension requiring treatment with more than three drugs
- •AV block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcF-interval (males >450 and females >470 msec)
- •Uncontrolled diabetes defined by HbA1c >8.5
- •Malignant tumors within the last five years except skin malignancies (other than melanoma) or indolent prostate cancer
- •Metastases
- •Dysphagia, or any inability to swallow capsules, any known malabsorption or malassimilation syndromes and any gastrointestinal condition which might affect drug absorption, as judged by the investigator.
- •5.Disability that may prevent the volunteer from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.)
- •6.Contraindication to lumbar puncture
- •7.Women who are fertile and of childbearing potential
- •8.Chronic daily drug intake of = 14 days or expected for = 14 days:
- •Benzodiazepines, neuroleptics or major sedatives
- •Antiepileptics
- •Centrally active anti-hypertensive drugs (clonidine, l-methyl DOPA, guanidine, guanfacine, etc.)
- •Opioid containing analgesics
- •9.Suspected or known drug or alcohol abuse, i.e., more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) per day indicated by elevated MCV significantly above normal value at screening in the absence of other etiology.
- •10.Suspected or known allergy to any components of the study treatments
- •11.Enrollment in another investigational study or intake of investigational drug within the previous three months
- •12.Any condition, which, in the opinion of the Investigator, makes the volunteer unsuitable for inclusion
研究者
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