NCT00999284

Ophthalmologic Examinations After Infusion of ZK200775

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: Male
• Age: 55 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Visual Acuity

Interventions

Type	Name	Description
DRUG	ZK200775	Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours.
DRUG	ZK200775	Intravenous infusion of 0.75 mg/kg/h of ZK200775 over a period of 4 hours.
DRUG	Sodium Chloride	Intravenous infusion of sodium chloride over a period of 4 hours.

Timeline

• Start date: 1996-12-01
• Primary completion: 1998-04-01
• Completion: 1998-04-01
• First posted: 2009-10-21
• Last updated: 2009-10-21

Locations

1 site across 1 country: Germany