Uric Acid Study in Healthy Male Volunteers

NCT00738842 | Completed Phase 1

• 1 other identifier: D5130C00050
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gout; Coronary Artery Disease

Keywords

Uric; Acid; Level

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD6140

2

PLACEBO COMPARATOR

Drug: Placebo to match AZD6140

Interventions

AZD6140 DRUG

Oral tablets taken bid for 5 days

1

Placebo to match AZD6140 DRUG

Oral tablets taken bid for 5 days

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Gout; Coronary Artery Disease; Heartburn

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Kathleen Butler, MD

  AstraZeneca

  STUDY DIRECTOR

• Stuart Harris, MD

  SeaView Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 21, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 3, 2010

Record last verified: 2010-12