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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: AZD9056; Drug: Placebo

• Registration Number: NCT00700986
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-18
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-30
• Last Update Posted: 2010-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD9056	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom