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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: AZD9056
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD9056<br>* Oral tablet, 800mg, one single administration<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of a single dose of AZD9056 (800mg) on retinal function will be assessed by Electroretinography |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroretinography, Rheumatoid Arthritis, Anti-TNF, Disease Modifying Anti-Rheumatic Drugs (DMARD)