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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT No. 2008-000752-27 |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD9056 | Drug | Oral tablet, 800mg, one single administration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of a single dose of AZD9056 (800mg) on retinal function will be assessed by Electroretinography | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Fahy, MA, MBBS (Hons) | AstraZeneca Clinical Pharmacology Unit, Nottingham | Principal Investigator |
| Mark Layton, MD, MRCP (UK) | AstraZeneca Alderley Park | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nottingham | Nottinghamshire | United Kingdom |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000608601 | AZD9056 |
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| Drug |
Single dose |
|
| The effect of a single dose of AZD9056 (800mg) on occipital function will be assessed by measurements of visual evoked potential. |
| 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. |
| The effect of a single dose of AZD9056 (800mg) on cognitive function will be assessed by psychomotor testing. | 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. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |