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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00700986 |
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 |
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 |
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
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2: Placebo Comparator |
Drug: Placebo
Single dose
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, Nottinghamshire | |
Research Site | |
NOTTINGHAM, Nottinghamshire, United Kingdom |
Principal Investigator: | William Fahy, MA, MBBS (Hons) | AstraZeneca Clinical Pharmacology Unit, Nottingham |
Study Director: | Mark Layton, MD, MRCP (UK) | AstraZeneca Alderley Park |
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 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Electroretinography Rheumatoid Arthritis Anti-TNF Disease Modifying Anti-Rheumatic Drugs (DMARD) |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Healthy Rheumatic Diseases |
Immune System Diseases |