A Randomised, Double-Blind, Placebo-Controlled, 2-Period Cross-Over Study in Healthy Male Volunteers, to Investigate Retinal Function Following a Single 800mg Oral Dose of AZD9056

AstraZeneca1 site in 1 country12 target enrollmentJune 2008

ConditionsRheumatoid Arthritis

InterventionsAZD9056 Placebo

DrugsAZD9056 Placebo

Overview

Phase: Phase 1
Intervention: AZD9056
Conditions: Rheumatoid Arthritis
Sponsor: AstraZeneca
Enrollment: 12
Locations: 1
Primary Endpoint: The effect of a single dose of AZD9056 (800mg) on retinal function will be assessed by Electroretinography
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to determine whether treatment with a single 800mg dose of AZD9056, a medication which has been developed as a possible treatment for Rheumatoid Arthritis, has an effect on the function of the retina

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

August 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Volunteers must be able to undergo the Electroretinography assessments
•Volunteers must have an intra ocular pressure of less than 25mmHg and 6/6 vision

Exclusion Criteria

•Volunteers must pass a test that assesses whether they are at risk of narrow angle glaucoma
•Volunteers must not a family history of colour blindness, they must also pass a colour blindness test
•Volunteers must not have a history or current neurological or opthalmological (eye) disease

Arms & Interventions

1

Intervention: AZD9056

2

Intervention: Placebo

Outcomes

Primary Outcomes

The effect of a single dose of AZD9056 (800mg) on retinal function will be assessed by Electroretinography

Time Frame: Electroretinography measurements will be performed at baseline, 6 hours post dosing at both treatment and crossover placebo treatment visits, and at post study medical follow up visits.

Secondary Outcomes

The effect of a single dose of AZD9056 (800mg) on retinal function will be assessed by measurements of visual acuity, contrast sensitivity and colour vision.(Visual acuity, contrast sensitivity and colour vision measurements will be performed at a training visit, at baseline, 2.5 hours post dosing at both treatment and crossover placebo treatment visits, and at post study medical follow up visits.)
The effect of a single dose of AZD9056 (800mg) on occipital function will be assessed by measurements of visual evoked potential.(Visual evoked potential measurements will be performed at a training visit, at baseline, 4 hours post dosing at both treatment and crossover placebo treatment visits, and at post study medical follow up visits.)
The effect of a single dose of AZD9056 (800mg) on cognitive function will be assessed by psychomotor testing.(Psychomotor testing will be performed at a training visit, at baseline, 8.5 and 24 hours post dosing at both treatment and crossover placebo treatment visits, and at post study medical follow up visits.)