Ophthalmologic Examinations After Infusion of ZK200775

Study Overview
=================
Brief Summary
-----------------
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).

Official Title
-----------------
Ophthalmologic Examinations After 4-hour Infusion of ZK200775 in Healthy Elder Male Volunteers

Conditions
-----------------
Visual Acuity

Intervention / Treatment
-----------------
* Drug: ZK200775
* Drug: ZK200775
* Drug: Sodium Chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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% Male sex Written informed consent Physical examination: Probands must show normal findings without clinical relevance, mental and physical health is required; Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Sham infusion of sodium chloride 0.9% | Drug: Sodium Chloride<br>* Intravenous infusion of sodium chloride over a period of 4 hours.<br>|
| Active Comparator: Low dose arm<br>Infusion of 0.3 mg/kg/h ZK200775 over 4 hours | Drug: ZK200775<br>* Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours.<br>|
| Active Comparator: High dose arm<br>Infusion of 0.75 mg/kg/h ZK200775 over 4 hours | Drug: ZK200775<br>* Intravenous infusion of 0.75 mg/kg/h of ZK200775 over a period of 4 hours.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Color vision (Panel D-15 test), dark vision (adaptometer), full-field electroretinogram |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ZK200775 is tested for its effects on vision on healthy probands.