Uric Acid Study in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Gout; Coronary Artery Disease
• Interventions: Drug: AZD6140; Drug: Placebo to match AZD6140

• Registration Number: NCT00738842
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2008-08-20
• Study First Submitted QC: 2008-08-20
• Study First Posted: 2008-08-21
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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)

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Exclusion Criteria

• Personal or family history of gout, gouty arthritis, or renal stones

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD6140	-
2	Placebo to match AZD6140	-

Primary Outcome Measures

Name	Time	Method
The effect of AZD6140 on the levels of certain chemicals in subjects' blood and urine.	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

Name	Time	Method
The blood levels of AZD6140 in various subjects on the same diet.	following dosing during the first 5 days of the study
The effect of taking AZD6140 on the levels of certain hormones in urine	during the first 5 days of the study