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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00700986

Enrollment

Registered

2008-06-19

Start date

2008-06-30

Completion date

2008-08-31

Last updated

2010-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Electroretinography, Rheumatoid Arthritis, Anti-TNF, Disease Modifying Anti-Rheumatic Drugs (DMARD)

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

Interventions

DRUGAZD9056

Oral tablet, 800mg, one single administration

DRUGPlacebo

Single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026