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Uric Acid Study in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT00738842
Recruitment Status : Completed
First Posted : August 21, 2008
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Gout Coronary Artery Disease Drug: AZD6140 Drug: Placebo to match AZD6140 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738842


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

Responsible Party: Jay Horrow, MD, Medical Science Director, AZD6140, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00738842     History of Changes
Other Study ID Numbers: D5130C00050
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Uric
Acid
Level

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Uric Acid
Ticagrelor
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents