GoutPhase 1NCT02219516

Mild, Moderate and Severe Renal Impairment Study

A Phase 1 study testing RDEA3170 in people with Gout, run by Ardea Biosciences, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment. Read more about this study

Who is it for?: Ages 18 to 85 years, men only
Conditions the study is for: Gout
What is being tested?: RDEA3170
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 4 sitesUnited States
Study dates: 1 Aug 2014to 13 May 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 85 years
Men only
No healthy volunteers
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 with renal impairment, as determined at Screening, with creatinine clearance as calculated by the Cockcroft-Gault formula of 60 to < 90 mL/min (mild impairment), 30 to < 60 mL/min (moderate impairment), or 15 to < 30 mL/min (severe impairment), or a matched control subject (by age and body mass index) with a creatinine clearance of ≥ 90 mL/min.
Subject has a Screening serum urate level ≥ 4.5 mg/dL and ≤ 10 mg/dL

Who cannot join

Subject has a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
Subject has a history or suspicion of kidney stones.
Subject has a history of asthma.
Subject has undergone major surgery within 3 months prior to Day 1.
Subject has donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Study site
Knoxville, Tennessee, 37920
Study site
Lakewood, Colorado, 80228
Study site
Minneapolis, Minnesota, 55404
Study site
Orlando, Florida, 32809

Other trials in United States

About this study

Official title: A Phase 1, Single-Dose, Open Label, Pharmacokinetic and Pharmacodynamic Study of RDEA3170 in Adult Male Subjects With Mild, Moderate, and Severe Renal Impairment

This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.

Conditions: Gout
Being tested: RDEA3170
Medical subject headings: Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RDEA3170Drug

Study groups in NCT02219516
Study group	Role	What they receive
Cohort 1: Mild renal impairment	Experimental	RDEA3170 15 mg once daily fasted Receives: Drug: RDEA3170
Cohort 2: Moderate renal impairment	Experimental	RDEA3170 15 mg once daily fasted Receives: Drug: RDEA3170
Cohort 3: Severe renal impairment	Experimental	RDEA3170 15 mg once daily fasted Receives: Drug: RDEA3170
Cohort 4: Control subjects with normal renal function	Experimental	RDEA3170 15 mg once daily fasted Receives: Drug: RDEA3170

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax)
Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function
Measured: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function
Measured: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function
Measured: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)
AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function
Measured: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Apparent Terminal Half-life (t1/2)
t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function
Measured: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)
CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
Measured: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Total Body Clearance Corrected for Bioavailability (CL/F)
CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function
Measured: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)
CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
Measured: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose

Secondary outcomes (2)

Incidence of Treatment-Emergent Adverse Events
Measured: 5 weeks
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Measured: Screening, Day -1 ( -24, -21, -18, -and -12 hours predose), and Day 1 (within 30 minutes prior to dosing and at 3, 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours postdose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201413 May 2016

First posted19 Aug 2014 (estimated)
Study start1 Aug 2014
Primary completion30 Oct 2015
Study completion13 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02219516
Sponsor's protocol ID: RDEA3170-108
Status last verified: Mar 2017
First submitted: 15 Aug 2014
Last updated: 25 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Smith WB, Hall J, Berg JK, Kazimir M, Yamamoto A, Walker S, Lee CA, Shen Z, Wilson DM, Zhou D, Gillen M, Marbury TC. Effect of Renal Impairment on the Pharmacokinetics and Pharmacodynamics of Verinurad, a Selective Uric Acid Reabsorption Inhibitor. Clin Drug Investig. 2018 Aug;38(8):703-713. doi: 10.1007/s40261-018-0652-2.
PubMed 29949102

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Gout trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Single-Dose, Open Label, Pharmacokinetic and Pharmacodynamic Study of RDEA3170 in Adult Male Subjects With Mild, Moderate, and Severe Renal Impairment
ClinicalTrials.gov ID: NCT02219516
Acronym / sponsor ID: RDEA3170-108
Conditions: Gout
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
Study start: 1 Aug 2014 (actual)
Primary completion: 30 Oct 2015 (actual)
Study completion: 13 May 2016 (actual)
First posted: 19 Aug 2014 (estimated)
Results: Posted 25 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Cohort 1: Mild renal impairment	Experimental	Drug: RDEA3170RDEA3170 15 mg once daily fasted
Cohort 2: Moderate renal impairment	Experimental	Drug: RDEA3170RDEA3170 15 mg once daily fasted
Cohort 3: Severe renal impairment	Experimental	Drug: RDEA3170RDEA3170 15 mg once daily fasted
Cohort 4: Control subjects with normal renal function	Experimental	Drug: RDEA3170RDEA3170 15 mg once daily fasted

Who may qualify

Ages: 18 to 85 years
Sex: Male only
Healthy volunteers: Not 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 with renal impairment, as determined at Screening, with creatinine clearance as calculated by the Cockcroft-Gault formula of 60 to < 90 mL/min (mild impairment), 30 to < 60 mL/min (moderate impairment), or 15 to < 30 mL/min (severe impairment), or a matched control subject (by age and body mass index) with a creatinine clearance of ≥ 90 mL/min.
Subject has a Screening serum urate level ≥ 4.5 mg/dL and ≤ 10 mg/dL

Key exclusion criteria (5 listed)

Subject has a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
Subject has a history or suspicion of kidney stones.
Subject has a history of asthma.
Subject has undergone major surgery within 3 months prior to Day 1.
Subject has donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation

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	Drug	Cohort 1: Mild renal impairment, Cohort 2: Moderate renal impairment, Cohort 3: Severe renal impairment, Cohort 4: Control subjects with normal renal function

Primary outcome

Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function
Time of Occurrence of Maximum Observed Concentration (Tmax)
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function
Apparent Terminal Half-life (t1/2)
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function
Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
Total Body Clearance Corrected for Bioavailability (CL/F)
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function
Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function

2 secondary outcomes

Incidence of Treatment-Emergent Adverse Events
Time frame: 5 weeks
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Time frame: Screening, Day -1 ( -24, -21, -18, -and -12 hours predose), and Day 1 (within 30 minutes prior to dosing and at 3, 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours postdose)

Results and safety

Results posted to the registry on 25 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg	8	8
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg	8	8
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg	7	7
Cohort 4: Normal Renal Function + RDEA3170 15 mg	8	8

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose. Geometric mean (95% Confidence Interval). Unit: ng/mL

Measure	Cohort 1: Mild Renal Impairment + RDEA3170 15 mg n = 8	Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg n = 8	Cohort 3: Severe Renal Impairment + RDEA3170 15 mg n = 7	Cohort 4: Normal Renal Function + RDEA3170 15 mg n = 8
Value	25.6 (20.0 to 32.9)	29.0 (22.8 to 37.0)	38.2 (24.0 to 60.8)	16.7 (12.6 to 22.3)

Cohort 1: Mild Renal Impairment + RDEA3170 15 mg vs Cohort 4: Normal Renal Function + RDEA3170 15 mg: Geometric Least Squares Mean Ratio (%): 153 (90% CI 115 to 203), Fixed Effects Model
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg vs Cohort 4: Normal Renal Function + RDEA3170 15 mg: Geometric Least Squares Mean Ratio (%): 173 (90% CI 131 to 230), Fixed Effects Model
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg vs Cohort 4: Normal Renal Function + RDEA3170 15 mg: Geometric Least Squares Mean Ratio (%): 228 (90% CI 155 to 336), Fixed Effects Model

Primary outcome: Time of Occurrence of Maximum Observed Concentration (Tmax)

Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose. Median (Full Range). Unit: hr

Measure	Cohort 1: Mild Renal Impairment + RDEA3170 15 mg n = 8	Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg n = 8	Cohort 3: Severe Renal Impairment + RDEA3170 15 mg n = 7	Cohort 4: Normal Renal Function + RDEA3170 15 mg n = 8
Value	2.50 (1.00 to 4.00)	3.00 (1.50 to 5.00)	2.00 (1.50 to 4.00)	2.50 (0.500 to 4.00)

Primary outcome: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)

Measure	Cohort 1: Mild Renal Impairment + RDEA3170 15 mg n = 8	Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg n = 8	Cohort 3: Severe Renal Impairment + RDEA3170 15 mg n = 7	Cohort 4: Normal Renal Function + RDEA3170 15 mg n = 8
Value	197 (142 to 273)	333 (246 to 451)	316 (179 to 559)	150 (123 to 182)

Cohort 1: Mild Renal Impairment + RDEA3170 15 mg vs Cohort 4: Normal Renal Function + RDEA3170 15 mg: Geometric Least Squares Mean Ratio (%): 131 (90% CI 98.6 to 174), Fixed Effects Model
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg vs Cohort 4: Normal Renal Function + RDEA3170 15 mg: Geometric Least Squares Mean Ratio (%): 222 (90% CI 171 to 287), Fixed Effects Model
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg vs Cohort 4: Normal Renal Function + RDEA3170 15 mg: Geometric Least Squares Mean Ratio (%): 211 (90% CI 139 to 319), Fixed Effects Model

Primary outcome: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)

Measure	Cohort 1: Mild Renal Impairment + RDEA3170 15 mg n = 8	Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg n = 8	Cohort 3: Severe Renal Impairment + RDEA3170 15 mg n = 7	Cohort 4: Normal Renal Function + RDEA3170 15 mg n = 8
Value	201 (144 to 279)	402 (225 to 634)	372 (209 to 663)	162 (120 to 218)

Cohort 1: Mild Renal Impairment + RDEA3170 15 mg vs Cohort 4: Normal Renal Function + RDEA3170 15 mg: Geometric Least Squares Mean Ratio (%): 124 (90% CI 88.8 to 173), Fixed Effects Model
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg vs Cohort 4: Normal Renal Function + RDEA3170 15 mg: Geometric Least Squares Mean Ratio (%): 248 (90% CI 168 to 366), Fixed Effects Model
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg vs Cohort 4: Normal Renal Function + RDEA3170 15 mg: Geometric Least Squares Mean Ratio (%): 230 (90% CI 146 to 363), Fixed Effects Model

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Mild Renal Impairment + RDEA3170 15 mg	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
Cohort 3: Severe Renal Impairment + RDEA3170 15 mg	0 of 7 (0%)	2 of 7 (28.6%)	Not reported
Cohort 4: Normal Renal Function + RDEA3170 15 mg	0 of 8 (0%)	1 of 8 (12.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29949102Smith WB, Hall J, Berg JK, Kazimir M, Yamamoto A, Walker S, Lee CA, Shen Z, Wilson DM, Zhou D, Gillen M, Marbury TC. Effect of Renal Impairment on the Pharmacokinetics and Pharmacodynamics of Verinurad, a Selective Uric Acid Reabsorption Inhibitor. Clin Drug Investig. 2018 Aug;38(8):703-713. doi: 10.1007/s40261-018-0652-2.

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.

4 sites 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 in people with Gout, run by Ardea Biosciences, Inc. at 4 sites 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 5 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 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Plasma Concentration (Cmax) (time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02219516, which also lists 1 linked publication.

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 25 Apr 2017.