Uric Acid Study in Healthy Male Volunteers

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00738842
• Collaborator: (none)
• Enrollment: 24
• Arms: 2
• Duration (Months): 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gout; Coronary Artery Disease	Drug: AZD6140; Drug: Placebo to match AZD6140	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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

1. The blood levels of AZD6140 in various subjects on the same diet. [following dosing during the first 5 days of the study]

2. The effect of taking AZD6140 on the levels of certain hormones in urine [during the first 5 days of the study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Kathleen Butler, MD, AstraZeneca
• Principal Investigator: Stuart Harris, MD, SeaView Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00738842
• Other Study ID Numbers: D5130C00050
• First Posted: Aug 21, 2008
• Last Update Posted: Dec 3, 2010
• Last Verified: Dec 1, 2010

• Keywords provided by , ,: Uric; Acid; Level
• Additional relevant MeSH terms: Coronary Artery Disease; Ticagrelor

Study Results

No Results Posted as of Dec 3, 2010