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

No publications provided

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 History of Changes
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
Antirheumatic Agents

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Therapeutic Uses
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009