Cross-Over Study to Investigate Retinal Function Following Administration of a Single Dose of AZD9056 - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00700986

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: AZD9056 Drug: Placebo	Phase I

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	June 2008
Study Completion Date:	September 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AZD9056 Oral tablet, 800mg, one single administration
2: Placebo Comparator	Drug: Placebo Single dose

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700986

Locations

United Kingdom, Nottinghamshire
Research Site
NOTTINGHAM, Nottinghamshire, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	William Fahy, MA, MBBS (Hons)	AstraZeneca Clinical Pharmacology Unit, Nottingham
Study Director:	Mark Layton, MD, MRCP (UK)	AstraZeneca Alderley Park

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Dr Mark Layton MD, MRCP (UK), Medicine Science Director )
Study ID Numbers:	D1520C00020, EUDRACT No. 2008-000752-27
Study First Received:	June 18, 2008
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00700986
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

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

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Healthy
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009