GoutPhase 1NCT00738842
Uric Acid Study in Healthy Male Volunteers
A Phase 1 study testing AZD6140 in people with Gout and Coronary Artery Disease, run by AstraZeneca.
Trial summary
This study is being conducted to examine the effect of AZD6140 on the levels of certain chemicals in subjects' blood and urine. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gout, Coronary Artery Disease
- What is being tested?
- AZD6140
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Jul 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Personal or family history of gout, gouty arthritis, or renal stones
About this study
Official title: 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.
- Conditions
- Gout, Coronary Artery Disease
- Being tested
- AZD6140, Placebo to match AZD6140
- Keywords
- Uric, Acid, Level
- Medical subject headings
- Gout, Coronary Artery Disease, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6140Drug
Oral tablets taken bid for 5 days
Placebo to match AZD6140Drug
Oral tablets taken bid for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD6140 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo to match AZD6140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of AZD6140 on the levels of certain chemicals in subjects' blood and urine.
Measured: 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.
Measured: following dosing during the first 5 days of the study
The effect of taking AZD6140 on the levels of certain hormones in urine
Measured: during the first 5 days of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kathleen Butler, MD, Study director, AstraZenecaStuart Harris, MD, Principal investigator, SeaView Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738842
- Sponsor's protocol ID
- D5130C00050
- Status last verified
- Dec 2010
- First submitted
- 20 Aug 2008
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Two-Period Crossover Study to Assess the Effect of AZD6140 on Uric Acid Levels in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00738842
- Acronym / sponsor ID
- D5130C00050
- Conditions
- Gout, Coronary Artery Disease
- Keywords
- Uric, Acid, Level
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 21 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to examine the effect of AZD6140 on the levels of certain chemicals in subjects' blood and urine.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD6140 |
| 2 | Placebo comparator | Drug: Placebo to match AZD6140 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Personal or family history of gout, gouty arthritis, or renal stones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD6140Oral tablets taken bid for 5 days | Drug | 1 |
| Placebo to match AZD6140Oral tablets taken bid for 5 days | Drug | 2 |
Primary outcome
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.
2 secondary outcomes
The blood levels of AZD6140 in various subjects on the same diet.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Butler, MD study director
AstraZeneca
Stuart Harris, MD principal investigator
SeaView Research
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD6140 in people with Gout and Coronary Artery Disease, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2010.