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Uric Acid Study in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00738842
First received: August 20, 2008
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  Purpose

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
Gout
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738842

Sponsors and Collaborators
AstraZeneca
Investigators
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
ClinicalTrials.gov 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:
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
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013