GoutPhase 1NCT02608710
RDEA3170 PK/PD Study
A Phase 1 study testing RDEA3170 4.5 mg, RDEA3170 6 mg and RDEA3170 12 mg in people with Gout, run by Ardea Biosciences, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gout
- What is being tested?
- RDEA3170 4.5 mg, RDEA3170 6 mg and RDEA3170 12 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Apr 2016
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
- Subject has a Screening serum urate level 4 to 7 mg/dL
- Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.
Who cannot join
- Subject has a history or suspicion of kidney stones.
- Subject has undergone major surgery within 3 months prior to Screening.
- Subject donated blood or experienced significant blood loss within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1.
- Subject has clinically unacceptable physical examination, per the Investigator's judgment.
- Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment.
- Subject has Screening clinical safety laboratory parameters (serum chemistry [other than serum creatinine and serum urate], hematology, coagulation or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator.
Show all 10Show fewer
- Subject has a serum creatinine value above the upper limit of normal at the Screening visit.
- Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment.
- Subject has a history of cardiac abnormalities
- Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-Label Study in Healthy Adult Male Subjects to Assess the Pharmacokinetics and Pharmacodynamics of RDEA3170
The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses
- Conditions
- Gout
- Being tested
- RDEA3170 4.5 mg, RDEA3170 6 mg, RDEA3170 12 mg
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDEA3170 4.5 mgDrug
RDEA3170 6 mgDrug
RDEA3170 12 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Single Dose | Experimental | Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9. Receives: Drug: RDEA3170 4.5 mg; Drug: RDEA3170 6 mg; Drug: RDEA3170 12 mg |
| Multiple Dose | Experimental | RDEA3170 12 mg once daily (qd) Receives: Drug: RDEA3170 12 mg |
| Single Dose Food Effect | Experimental | Since dose of RDEA3170 6 mg administered in fed or fasted state on Day 1 and Day 8. Receives: Drug: RDEA3170 6 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Measured: Days -1, 1, 5 and 9
Cmax
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
Measured: Days -1, 1 and 7
Cmax
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
Measured: Days -1, 1, 7 and 8
Time of Occurrence of maximum observed concentration (Tmax)
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Measured: Days -1, 1, 5 and 9
Area under the plasma concentration time curve (AUC)
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Measured: Days -1, 1, 5 and 9
Tmax
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
Measured: Days -1, 1 and 7
AUC
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
Measured: Days -1, 1 and 7
Tmax
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
Measured: Days -1, 1, 7 and 8
AUC
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
Measured: Days -1, 1, 7 and 8
Serum urate concentration
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Measured: Days -1, 1, 5 and 9
Urine uric acid excretion amount
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Measured: Days -1, 1, 5 and 9
Renal clearance of uric acid
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Measured: Days -1, 1, 5 and 9
Fractional excretion of uric acid
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Measured: Days -1, 1, 5 and 9
Serum urate concentration
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
Measured: Days -1, 1 and 7
Urine uric acid excretion amount
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
Measured: Days -1, 1 and 7
Renal clearance of uric acid
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
Measured: Days -1, 1 and 7
Fractional excretion of uric acid
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
Measured: Days -1, 1 and 7
Serum urate concentration
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Measured: Days -1, 1, 7 and 8
Urine uric acid excretion amount
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Measured: Days -1, 1, 7 and 8
Renal Clearance of Uric Acid
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Measured: Days -1, 1, 7 and 8
Fractional excretion of uric acid
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Measured: Days -1, 1, 7 and 8
Secondary outcomes (7)
Incidence of Adverse Events in terms of changes in laboratory parameters
Measured: 6 weeks
Incidence of Adverse Events in terms of electrocardiogram parameters
Measured: 6 weeks
Incidence of Adverse Events in terms of vital signs
Measured: 6 weeks
Incidence of Adverse Events in terms of physical examination findings
Measured: 6 weeks
Apparent terminal half-life (t1/2)
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg from plasma and urine
Measured: Days -1, 1, 5 and 9
t1/2
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
Measured: Days -1, 1, 7 and 8
t1/2
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg from plasma and urine
Measured: Days -1, 1 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionApr 2016
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ardea Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. Hall, MD, Study director, Ardea Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608710
- Sponsor's protocol ID
- RDEA3170-112
- Status last verified
- Aug 2016
- First submitted
- 15 Nov 2015
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label Study in Healthy Adult Male Subjects to Assess the Pharmacokinetics and Pharmacodynamics of RDEA3170
- ClinicalTrials.gov ID
- NCT02608710
- Acronym / sponsor ID
- RDEA3170-112
- Conditions
- Gout
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Nov 2015 (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.
The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Dose | Experimental | Drug: RDEA3170 4.5 mg, Drug: RDEA3170 6 mg, Drug: RDEA3170 12 mgSingle dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9. |
| Multiple Dose | Experimental | Drug: RDEA3170 12 mgRDEA3170 12 mg once daily (qd) |
| Single Dose Food Effect | Experimental | Drug: RDEA3170 6 mgSince dose of RDEA3170 6 mg administered in fed or fasted state on Day 1 and Day 8. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
- Subject has a Screening serum urate level 4 to 7 mg/dL
- Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.
Key exclusion criteria (10 listed)
- Subject has a history or suspicion of kidney stones.
- Subject has undergone major surgery within 3 months prior to Screening.
- Subject donated blood or experienced significant blood loss within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1.
- Subject has clinically unacceptable physical examination, per the Investigator's judgment.
- Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment.
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 4.5 mg | Drug | Single Dose |
| RDEA3170 6 mg | Drug | Single Dose, Single Dose Food Effect |
| RDEA3170 12 mg | Drug | Multiple Dose, Single Dose |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Cmax
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
Cmax
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
Time of Occurrence of maximum observed concentration (Tmax)
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Area under the plasma concentration time curve (AUC)
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Tmax
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
AUC
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
Tmax
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
AUC
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
Serum urate concentration
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Urine uric acid excretion amount
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Renal clearance of uric acid
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Fractional excretion of uric acid
Time frame: Days -1, 1, 5 and 9
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Serum urate concentration
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
Urine uric acid excretion amount
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
Renal clearance of uric acid
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
Fractional excretion of uric acid
Time frame: Days -1, 1 and 7
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
Serum urate concentration
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Urine uric acid excretion amount
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Renal Clearance of Uric Acid
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Fractional excretion of uric acid
Time frame: Days -1, 1, 7 and 8
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
7 secondary outcomes
Incidence of Adverse Events in terms of changes in laboratory parameters
Time frame: 6 weeks
Incidence of Adverse Events in terms of electrocardiogram parameters
Time frame: 6 weeks
Incidence of Adverse Events in terms of vital signs
Time frame: 6 weeks
Incidence of Adverse Events in terms of physical examination findings
Time frame: 6 weeks
Apparent terminal half-life (t1/2)
Time frame: Days -1, 1, 5 and 9
t1/2
Time frame: Days -1, 1, 7 and 8
t1/2
Time frame: Days -1, 1 and 7
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 2 Sep 2016.
Related trials for Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy
Recruiting
Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout
Gout, Gouty Arthritis
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.
J. Hall, 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 testing RDEA3170 4.5 mg, RDEA3170 6 mg and RDEA3170 12 mg in people with 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 3 inclusion and 10 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 2 Sep 2016. 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?
Maximum observed concentration (Cmax) (time frame: Days -1, 1, 5 and 9). The study lists 21 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 2 Sep 2016.