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

NCT ID: NCT00700986

Last Updated: 2010-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

AZD9056

Intervention Type DRUG

Oral tablet, 800mg, one single administration

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose

Interventions

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AZD9056

Oral tablet, 800mg, one single administration

Intervention Type DRUG

Placebo

Single dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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William Fahy, MA, MBBS (Hons)

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca Clinical Pharmacology Unit, Nottingham

Mark Layton, MD, MRCP (UK)

Role: STUDY_DIRECTOR

AstraZeneca Alderley Park

Locations

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Research Site

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EUDRACT No. 2008-000752-27

Identifier Type: -

Identifier Source: secondary_id

D1520C00020

Identifier Type: -

Identifier Source: org_study_id