- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00738842
Uric Acid Study in Healthy Male Volunteers
December 2, 2010 updated by: AstraZeneca
A Randomised, Double-Blind, Two-Period Crossover Study to Assess the Effect of AZD6140 on Uric Acid Levels 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: 2
|
Oral tablets taken bid for 5 days
|
EXPERIMENTAL: 1
|
Oral tablets taken bid for 5 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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
Outcome Measure |
Time Frame |
---|---|
The blood levels of AZD6140 in various subjects on the same diet.
Time Frame: following dosing during the first 5 days of the study
|
following dosing during the first 5 days of the study
|
The effect of taking AZD6140 on the levels of certain hormones in urine
Time Frame: during the first 5 days of the study
|
during the first 5 days of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stuart Harris, MD, SeaView Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (ACTUAL)
July 1, 2008
Study Completion (ACTUAL)
July 1, 2008
Study Registration Dates
First Submitted
August 20, 2008
First Submitted That Met QC Criteria
August 20, 2008
First Posted (ESTIMATE)
August 21, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
December 3, 2010
Last Update Submitted That Met QC Criteria
December 2, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
Other Study ID Numbers
- D5130C00050
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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