Status:
COMPLETED
Ophthalmologic Examinations After Infusion of ZK200775
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Bayer
Conditions:
Visual Acuity
Eligibility:
MALE
55-65 years
Phase:
PHASE1
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 1998
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00999284
Start Date
December 1 1996
End Date
April 1 1998
Last Update
October 21 2009
Active Locations (1)
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1
Charité Unviversitätsmedizin Berlin, Augenklinik Campus Virchow-Klinikum
Berlin, State of Berlin, Germany, 13353