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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00700986
First received: June 18, 2008
Last updated: November 30, 2010
Last verified: November 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
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

Resource links provided by NLM:


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: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD9056
Oral tablet, 800mg, one single administration
Placebo Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
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: Dr Mark Layton MD, MRCP (UK), Medicine Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00700986     History of Changes
Other Study ID Numbers: D1520C00020, EUDRACT No. 2008-000752-27
Study First Received: June 18, 2008
Last Updated: November 30, 2010
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)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 02, 2014