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Uric Acid Study in Healthy Male Volunteers

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: August 20, 2008
Last updated: December 2, 2010
Last verified: December 2010

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

Condition Intervention Phase
Coronary Artery Disease
Drug: AZD6140
Drug: Placebo to match AZD6140
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomised, Double-Blind, Two-Period Crossover Study to Assess the Effect of AZD6140 on Uric Acid Levels in Healthy Male Volunteers

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The blood levels of AZD6140 in various subjects on the same diet. [ Time Frame: following dosing during the first 5 days of the study ] [ Designated as safety issue: No ]
  • The effect of taking AZD6140 on the levels of certain hormones in urine [ Time Frame: during the first 5 days of the study ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD6140
Oral tablets taken bid for 5 days
Placebo Comparator: 2 Drug: Placebo to match AZD6140
Oral tablets taken bid for 5 days


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  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 identifier: NCT00738842

Sponsors and Collaborators
Study Director: Kathleen Butler, MD AstraZeneca
Principal Investigator: Stuart Harris, MD SeaView Research
  More Information

No publications provided

Responsible Party: Jay Horrow, MD, Medical Science Director, AZD6140, AstraZeneca Pharmaceuticals Identifier: NCT00738842     History of Changes
Other Study ID Numbers: D5130C00050
Study First Received: August 20, 2008
Last Updated: December 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists processed this record on November 20, 2014