Uric Acid Study in Healthy Male Volunteers

Coronary Artery Disease Clinical Trial

Official title:

A Randomised, Double-Blind, Two-Period Crossover Study to Assess the Effect of AZD6140 on Uric Acid Levels in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738842
• Other study ID #: D5130C00050
• Status: Completed
• Phase: Phase 1
• First received: August 20, 2008
• Last updated: December 2, 2010
• Start date: May 2008
• Est. completion date: July 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Gout
• Myocardial Ischemia

Intervention

Drug:
• AZD6140
Oral tablets taken bid for 5 days
• Placebo to match AZD6140
Oral tablets taken bid for 5 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	The blood levels of AZD6140 in various subjects on the same diet.		following dosing during the first 5 days of the study	No
Secondary	The effect of taking AZD6140 on the levels of certain hormones in urine		during the first 5 days of the study	No