Ophthalmologic Examinations After 4-hour Infusion of ZK200775 in Healthy Elder Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
ZK 200775 is an antagonist at the α-Amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA) receptor and had earned attention a possible neuroprotective agent in cerebral ischemia. Probands receiving the agent within a stroke therapy related Phase I trial reported on an alteration of visual perception. In this trial, the effects of ZK 200775 on the visual system will be analyzed in detail.
In a randomised, placebo-controlled, double-blind study eyes and vision will be examined before and after the intravenous administration of ZK 200775. The following methods will be applied: clinical examination, visual acuity, ophthalmoscopy, colour vision, rod absolute threshold, central visual field, pattern-reversal visual evoked potentials (pVEP), ON-OFF and full-field electroretinogram (ERG).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The participant must be a voluntary proband
- •Age between 55 and 65 years
- •Body weight must not exceed the following value: Body height in cm minus 100 = body weight [kg] +/- 20%
- •Written informed consent
- •Physical examination: Probands must show normal findings without clinical relevance, mental and physical health is required;
排除标准
- •Clinical history:
- •Substantial pre-existing medical condition
- •Known allergy to the employed effective components or galenic components
- •Medicaments and drugs
- •Intake of systemically or locally acting drugs which conflict with the aim of the trial or that can influence the results (antipsychotic drugs, antidepressants, barbiturates and benzodiazepines)
- •A clinical history that hints to substance or alcohol abuse
- •Nicotine abuse of more than 10 cigarettes a day
- •Consumption of alcoholic beverages on the day prior to the examinations
- •Extreme physical stress (sports or work) within 8 days prior to the examinations
- •Blood donation within 2 months prior to the examinations
- •Relevant vaccination or stay abroad
- •Special or onesided alimentation (strict vegetarianism, low-caloric diet)
- •Simultaneous participation in another clinical trial
- •Vital signs (after 3 minutes of rest)
- •Blood pressure with systolic values > 160 mmHg and / or diastolic values > 95 mmHg
- •Heart frequency: Values beyond 50-100 beats per minute
- •Electrocardiogram
- •abnormal 12-channel ECG
- •Laboratory findings
- •Hepatitis antigen (HBsAG), hepatitis C-antibodies or positive HIV-test
- •Clinical pharmacology
- •positive drug test
- •clinically relevant abnormalities of the examined parameters
- •Opinion of the investigator: when due to scientific or personal reasons or matters of compliance or safety a patient should not take part in the trial
- •Opacification of optic media, retinal disease, optic nerve disease, amblyopia or color vision defects
- •Status post intraocular surgery (exception: cataract surgery with implantation of a posterior chamber lens), laser coagulation
- •Myopia > -5 diopters, hyperopia > +5 diopters
- •Narrow angle glaucoma
研究组 & 干预措施
Placebo
Sham infusion of sodium chloride 0.9%
干预措施: Sodium Chloride (Drug)
Low dose arm
Infusion of 0.3 mg/kg/h ZK200775 over 4 hours
干预措施: ZK200775 (Drug)
High dose arm
Infusion of 0.75 mg/kg/h ZK200775 over 4 hours
干预措施: ZK200775 (Drug)
结局指标
主要结局
Visual acuity
次要结局
- Color vision (Panel D-15 test), dark vision (adaptometer), full-field electroretinogram