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

Rheumatoid Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700986
• Other study ID #: D1520C00020
• Secondary ID: EUDRACT No. 2008
• Status: Completed
• Phase: Phase 1
• First received: June 18, 2008
• Last updated: November 30, 2010
• Start date: June 2008
• Est. completion date: August 2008

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• AZD9056
Oral tablet, 800mg, one single administration
• Placebo
Single dose

Locations

Country	Name	City	State
United Kingdom	Research Site	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	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.	Yes