Cross-over Study to Investigate Retinal Function Following Administration of a Single Dose of AZD9056

AstraZeneca12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

AZD9056DRUG

Oral tablet, 800mg, one single administration

PlaceboDRUG

Single dose

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Nottingham, Nottinghamshire, United Kingdom

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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