GoutPhase 1NCT01872832
Single and Multiple Dose Study in Japanese Subjects
A Phase 1 study of Gout, run by Ardea Biosciences, Inc. at 1 site in United States.
Trial summary
This study will explore the safety, tolerability, and serum uric acid lowering effect of RDEA3170 in healthy Japanese males to allow comparison with the Western population. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gout
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Nov 2013
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand the study procedures and the risks involved, and willing to provide written informed consent before the first study related activity.
- Healthy adult male subject born in Japan.
- Subject has parents and grandparents who are Japanese.
- Subject is in possession of a valid Japanese passport.
- All laboratory parameters should be within normal limits or considered not clinically significant by the investigator.
- Screening serum urate level ≥ 4.5 mg/dL.
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- Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
- Subject has a normal or clinically acceptable physical examination.
- Subject has no clinically relevant abnormalities in blood pressure, heart rate, and body temperature, per the Investigator's judgment.
Who cannot join
- Positive serology to human immunodeficiency virus (HIV-1 or HIV-2).
- Positive test for active hepatitis B or hepatitis C infection.
- History or suspicion of kidney stones.
- Undergone major surgery within 3 months prior to Day 1.
- Exposed to an investigational drug (or a medical device) within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to Day 1 or is currently participating in another study of an investigational drug (or medical device).
- Prior exposure to RDEA3170.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Single-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RDEA3170 in Healthy Male Japanese Subjects
This study will explore the safety, tolerability, and serum uric acid lowering effect of RDEA3170 in healthy Japanese males to allow comparison with the Western population.
Read the detailed description
While clinical studies of RDEA3170 to date have been limited to a Western population, it is recognized that both intrinsic and extrinsic factors may impact the PK, PD, safety, and dose response in different ethnic populations. The purpose of this study is to explore the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of single and multiple doses of RDEA3170 in healthy Japanese males, and to allow comparison of these parameters with the Western population.
- Conditions
- Gout
- Being tested
- RDEA3170 and Placebo
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDEA3170 and PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 5 mg RDEA3170 | Experimental | RDEA3170 5 mg or placebo fasted and fed Receives: Drug: RDEA3170 and Placebo |
| 10 mg RDEA3170 | Experimental | RDEA3170 10 mg or placebo fasted and fed Receives: Drug: RDEA3170 and Placebo |
| 15 mg RDEA3170 | Experimental | RDEA3170 15 mg or placebo fasted and fed Receives: Drug: RDEA3170 and Placebo |
| 2.5 mg RDEA3170 | Experimental | RDEA3170 2.5 mg or placebo fasted and fed Receives: Drug: RDEA3170 and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
Measured: 5 to 6 weeks
PK profile of RDEA3170 from plasma and urine
Profile in terms of AUC, Tmax, Cmax, and t1/2
AUC: area under the plasma concentration versus time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life
Measured: Day 1 through 15
PD profile of RDEA3170 from serum and urine
Profile in terms of sUA concentration; CLr; urine uric acid excretion amount; fractional excretion of uric acid
sUA: serume urate; CLr: renal clearance
Measured: Day 1 through 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionNov 2013
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardea Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S Baumgartner, MD, Study director, Ardea Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872832
- Sponsor's protocol ID
- RDEA3170-104
- Status last verified
- Jan 2014
- First submitted
- 3 Jun 2013
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Single-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RDEA3170 in Healthy Male Japanese Subjects
- ClinicalTrials.gov ID
- NCT01872832
- Acronym / sponsor ID
- RDEA3170-104
- Conditions
- Gout
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 7 Jun 2013 (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 will explore the safety, tolerability, and serum uric acid lowering effect of RDEA3170 in healthy Japanese males to allow comparison with the Western population.
Detailed description
While clinical studies of RDEA3170 to date have been limited to a Western population, it is recognized that both intrinsic and extrinsic factors may impact the PK, PD, safety, and dose response in different ethnic populations. The purpose of this study is to explore the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of single and multiple doses of RDEA3170 in healthy Japanese males, and to allow comparison of these parameters with the Western population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 mg RDEA3170 | Experimental | Drug: RDEA3170 and PlaceboRDEA3170 5 mg or placebo fasted and fed |
| 10 mg RDEA3170 | Experimental | Drug: RDEA3170 and PlaceboRDEA3170 10 mg or placebo fasted and fed |
| 15 mg RDEA3170 | Experimental | Drug: RDEA3170 and PlaceboRDEA3170 15 mg or placebo fasted and fed |
| 2.5 mg RDEA3170 | Experimental | Drug: RDEA3170 and PlaceboRDEA3170 2.5 mg or placebo fasted and fed |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Able to understand the study procedures and the risks involved, and willing to provide written informed consent before the first study related activity.
- Healthy adult male subject born in Japan.
- Subject has parents and grandparents who are Japanese.
- Subject is in possession of a valid Japanese passport.
- All laboratory parameters should be within normal limits or considered not clinically significant by the investigator.
Key exclusion criteria (6 listed)
- Positive serology to human immunodeficiency virus (HIV-1 or HIV-2).
- Positive test for active hepatitis B or hepatitis C infection.
- History or suspicion of kidney stones.
- Undergone major surgery within 3 months prior to Day 1.
- Exposed to an investigational drug (or a medical device) within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to Day 1 or is currently participating in another study of an investigational drug (or medical device).
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 |
|---|---|---|
| RDEA3170 and Placebo | Drug | 10 mg RDEA3170, 15 mg RDEA3170, 2.5 mg RDEA3170, 5 mg RDEA3170 |
Primary outcome
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
Time frame: 5 to 6 weeks
PK profile of RDEA3170 from plasma and urine
Time frame: Day 1 through 15
Profile in terms of AUC, Tmax, Cmax, and t1/2 AUC: area under the plasma concentration versus time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life
PD profile of RDEA3170 from serum and urine
Time frame: Day 1 through 15
Profile in terms of sUA concentration; CLr; urine uric acid excretion amount; fractional excretion of uric acid sUA: serume urate; CLr: renal clearance
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 9 Jan 2014.
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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.
S Baumgartner, MD study director
Ardea Biosciences, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Gout, run by Ardea Biosciences, Inc. at 1 site in United States.
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 9 inclusion and 6 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 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters (time frame: 5 to 6 weeks). The study lists 3 primary outcomes in all. 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 9 Jan 2014.