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
Drug: Placebo to match AZD6140
Oral tablets taken bid for 5 days
EXPERIMENTAL: 1
Drug: AZD6140
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

AstraZeneca

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

Keywords

Additional Relevant MeSH Terms

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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