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Completed

NCT Number: NCT00738842

Uric Acid Study in Healthy Male Volunteers

This study is being conducted to examine the effect of AZD6140 on the levels of certain chemicals in subjects' blood and urine.

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Key information

Conditions

Gout Arterial Occlusive Diseases Arteriosclerosis Arthritis Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronary Artery Disease Coronary Disease Crystal Arthropathies Genetic Diseases, Inborn Heart Diseases Heartburn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases Signs and Symptoms Signs and Symptoms, Digestive Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal physical examination, vital signs, electrocardiogram (ECG) and laboratory values (unless the investigator considers an abnormality not to be clinically significant)
  • Normal laboratory tests at screening
  • Non-smoker (no cigarette/tobacco use for at least 6 months)

Exclusion criteria

  • Personal or family history of gout, gouty arthritis, or renal stones

Treatment and study plan

AZD6140

Drug

Oral tablets taken bid for 5 days

Placebo to match AZD6140

Drug

Oral tablets taken bid for 5 days

Primary outcomes

  1. The effect of AZD6140 on the levels of certain chemicals in subjects' blood and urine.

    Time frame: Levels or certain chemicals in subjects' blood and urine will be measured at scheduled times during the first 7 days of the study.

Secondary outcomes

  1. The blood levels of AZD6140 in various subjects on the same diet.

    Time frame: following dosing during the first 5 days of the study

  2. The effect of taking AZD6140 on the levels of certain hormones in urine

    Time frame: during the first 5 days of the study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Double-Blind, Two-Period Crossover Study to Assess the Effect of AZD6140 on Uric Acid Levels in Healthy Male Volunteers

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 21, 2008
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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