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Completed

NCT Number: NCT00700986

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Nottingham, Nottinghamshire, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD9056

Drug

Oral tablet, 800mg, one single administration

Placebo

Drug

Single dose

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 19, 2008
Registry last updated
Dec 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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