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

NCT00700986 | Completed Phase 1

• 2 other identifiers: D1520C00020EUDRACT No. 2008-000752-27
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD9056

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD9056 DRUG

Oral tablet, 800mg, one single administration

1

Placebo DRUG

Single dose

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers must be able to undergo the Electroretinography assessments
• Volunteers must have an intra ocular pressure of less than 25mmHg and 6/6 vision

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Nottingham, Nottinghamshire, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

AZD9056

Condition Hierarchy (Ancestors)

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

Study Officials

• William Fahy, MA, MBBS (Hons)

  AstraZeneca Clinical Pharmacology Unit, Nottingham

  PRINCIPAL INVESTIGATOR

• Mark Layton, MD, MRCP (UK)

  AstraZeneca Alderley Park

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 19, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 1, 2010

Record last verified: 2010-11

Locations

GB (1)