Back to resultsUric Acid Study in Healthy Male Volunteers
Primary Purpose
Gout, Coronary Artery Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AZD6140
Placebo to match AZD6140
Sponsored by
About this trial
This is an interventional basic science trial for Gout focused on measuring Uric, Acid, Level
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
The effect of AZD6140 on the levels of certain chemicals in subjects' blood and urine.
Secondary Outcome Measures
The blood levels of AZD6140 in various subjects on the same diet.
The effect of taking AZD6140 on the levels of certain hormones in urine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00738842
Brief Title
Uric Acid Study in Healthy Male Volunteers
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 Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being conducted to examine the effect of AZD6140 on the levels of certain chemicals in subjects' blood and urine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Coronary Artery Disease
Keywords
Uric, Acid, Level
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD6140
Intervention Description
Oral tablets taken bid for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo to match AZD6140
Intervention Description
Oral tablets taken bid for 5 days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The blood levels of AZD6140 in various subjects on the same diet.
Time Frame
following dosing during the first 5 days of the study
Title
The effect of taking AZD6140 on the levels of certain hormones in urine
Time Frame
during the first 5 days of the study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Butler, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stuart Harris, MD
Organizational Affiliation
SeaView Research
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Uric Acid Study in Healthy Male Volunteers
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