Clinical trial NCT00700986: Cross-over Study to Investigate Retinal Function Following Administration of a Single Dose of AZD9056
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Electroretinography
Rheumatoid Arthritis
Anti-TNF
Disease Modifying Anti-Rheumatic Drugs (DMARD)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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


Eligibility 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

Primary outcomes:
measure: The effect of a single dose of AZD9056 (800mg) on retinal function will be assessed by Electroretinography
timeFrame: 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:
measure: 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.
timeFrame: 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.
measure: The effect of a single dose of AZD9056 (800mg) on occipital function will be assessed by measurements of visual evoked potential.
timeFrame: 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.
measure: The effect of a single dose of AZD9056 (800mg) on cognitive function will be assessed by psychomotor testing.
timeFrame: 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.
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Research Site
state: Nottinghamshire
Study officials:
affiliation: AstraZeneca Clinical Pharmacology Unit, Nottingham
name: William Fahy, MA, MBBS (Hons)
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Alderley Park
name: Mark Layton, MD, MRCP (UK)
role: STUDY_DIRECTOR
References: