GoutPhase 1NCT02279641

RDEA3170 and Allopurinol Combination Study in Gout Subjects

A Phase 1 study testing RDEA3170 10 mg and allopurinol 300 mg in people with Gout, run by Ardea Biosciences, Inc. at 1 site in United States.

Completed

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

Official record

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Trial summary

This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of RDEA3170 or allopurinol alone and in combination in the fed state. Read more about this study

Who is it for?: Ages 18 to 75 years, men only
Conditions the study is for: Gout
What is being tested?: RDEA3170 10 mg and allopurinol 300 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2014to 11 Sep 2015
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 75 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45 kg/m2.
Subject has a Screening serum urate level ≥ 8 mg/dL and ≤ 10 mg/dL
Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Who cannot join

Subject is unable to take colchicine for gout flare prophylaxis.
Subject has a history or suspicion of kidney stones.
Subject has an estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight at Screening prior to Day -2.
Subject is on unstable doses of chronic medications. Subjects taking medications for chronic medical conditions must be on stable doses during the course of the study, including the Screening period. Dose adjustments are allowed if deemed medically necessary by the investigator and following discussion with the medical monitor
Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose linked transporter-2 inhibitors are permitted if the dose is stable for at least 14 days prior to study medication dosing.
Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: A Phase 1b, Randomized, Open-label Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between RDEA3170 and Allopurinol in Adult Male Subjects With Gout

Conditions: Gout
Being tested: RDEA3170 10 mg, allopurinol 300 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 10 mgDrug
allopurinol 300 mgDrug

Study groups in NCT02279641
Study group	Role	What they receive
Sequence A	Experimental	RDEA3170 qd (once daily), RDEA3170 + allopurinol qd, allopurinol qd Receives: Drug: RDEA3170 10 mg; Drug: allopurinol 300 mg
Sequence B	Experimental	allopurinol qd, RDEA3170 + allopurinol qd, RDEA3170 qd Receives: Drug: RDEA3170 10 mg; Drug: allopurinol 300 mg

What is being measured

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

Maximum Observed Plasma Concentration (Cmax)
Cmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Measured: 22 days
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Measured: 22 days
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
AUC 0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Measured: 22 days
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
AUC last of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Measured: 22 days
Apparent Terminal Half-life (t1/2)
t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Measured: 22 days
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Ae0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Measured: 22 days
Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)
CLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Measured: 22 days
Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine
Measured: 22 days
Maximum Observed Plasma Concentration (Cmax)
Cmax of RDEA3170 Alone and In Combination with Allopurinol
Measured: 22 days
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
AUC 0-24 of RDEA3170 Alone and In Combination with Allopurinol
Measured: 22 days
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
AUC last of RDEA3170 Alone and In Combination with Allopurinol
Measured: 22 days
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol
Measured: 22 days

Secondary outcomes (1)

Incidence of Treatment-Emergent Adverse Events
Measured: 22 days

Timeline

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

1 Nov 201411 Sep 2015

First posted31 Oct 2014 (estimated)
Study start1 Nov 2014
Primary completion6 Apr 2015
Study completion11 Sep 2015

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.
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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02279641
Sponsor's protocol ID: RDEA3170-107
Status last verified: Dec 2017
First submitted: 28 Oct 2014
Last updated: 20 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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All Gout trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b, Randomized, Open-label Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between RDEA3170 and Allopurinol in Adult Male Subjects With Gout
ClinicalTrials.gov ID: NCT02279641
Acronym / sponsor ID: RDEA3170-107
Conditions: Gout
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
Study start: 1 Nov 2014 (actual)
Primary completion: 6 Apr 2015 (actual)
Study completion: 11 Sep 2015 (actual)
First posted: 31 Oct 2014 (estimated)
Results: Posted 20 Dec 2017

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence A	Experimental	Drug: RDEA3170 10 mg, Drug: allopurinol 300 mgRDEA3170 qd (once daily), RDEA3170 + allopurinol qd, allopurinol qd
Sequence B	Experimental	Drug: RDEA3170 10 mg, Drug: allopurinol 300 mgallopurinol qd, RDEA3170 + allopurinol qd, RDEA3170 qd

Who may qualify

Ages: 18 to 75 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45 kg/m2.
Subject has a Screening serum urate level ≥ 8 mg/dL and ≤ 10 mg/dL
Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Key exclusion criteria (6 listed)

Subject is unable to take colchicine for gout flare prophylaxis.
Subject has a history or suspicion of kidney stones.
Subject has an estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight at Screening prior to Day -2.
Subject is on unstable doses of chronic medications. Subjects taking medications for chronic medical conditions must be on stable doses during the course of the study, including the Screening period. Dose adjustments are allowed if deemed medically necessary by the investigator and following discussion with the medical monitor
Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose linked transporter-2 inhibitors are permitted if the dose is stable for at least 14 days prior to study medication dosing.

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 10 mg	Drug	Sequence A, Sequence B
allopurinol 300 mg	Drug	Sequence A, Sequence B

Primary outcome

Maximum Observed Plasma Concentration (Cmax)
Time frame: 22 days
Cmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Time of Occurrence of Maximum Observed Concentration (Tmax)
Time frame: 22 days
Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
Time frame: 22 days
AUC 0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
Time frame: 22 days
AUC last of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Apparent Terminal Half-life (t1/2)
Time frame: 22 days
t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Time frame: 22 days
Ae0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)
Time frame: 22 days
CLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine
Time frame: 22 days
Maximum Observed Plasma Concentration (Cmax)
Time frame: 22 days
Cmax of RDEA3170 Alone and In Combination with Allopurinol
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
Time frame: 22 days
AUC 0-24 of RDEA3170 Alone and In Combination with Allopurinol
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
Time frame: 22 days
AUC last of RDEA3170 Alone and In Combination with Allopurinol
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Time frame: 22 days
Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol

1 secondary outcome

Incidence of Treatment-Emergent Adverse Events
Time frame: 22 days

Results and safety

Results posted to the registry on 20 Dec 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
RDEA3170 or Allopurinol Alone and in Combination (Sequence A)	6	6
RDEA3170 or Allopurinol Alone and in Combination (Sequence B)	6	6

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: 22 days. Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	Allopurinol: Allopurinol Alone n = 12	Allopurinol: RDEA3170 + Allopurinol n = 12	Oxypurinol: Allopurinol Alone n = 12	Oxypurinol: RDEA3170 + Allopurinol n = 12
Value	1.13 (0.894 to 1.43)	1.51 (1.24 to 1.82)	12.8 (11.7 to 14.0)	8.68 (7.99 to 9.43)

Allopurinol: Allopurinol Alone vs Allopurinol: RDEA3170 + Allopurinol: Geometric Least Squares Mean Ratio (%): 133 (90% CI 111 to 159), Mixed Models Analysis
Oxypurinol: Allopurinol Alone vs Oxypurinol: RDEA3170 + Allopurinol: Geometric Least Squares Mean Ratio (%): 67.9 (90% CI 65.2 to 70.7), Mixed Models Analysis

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

Time frame: 22 days. Median (Full Range). Unit: hr

Measure	Allopurinol: Allopurinol Alone n = 12	Allopurinol: RDEA3170 + Allopurinol n = 12	Oxypurinol: Allopurinol Alone n = 12	Oxypurinol: RDEA3170 + Allopurinol n = 12	RDEA3170: RDEA3170 Alone n = 12	RDEA3170: RDEA3170 + Allopurinol n = 12
Value	1.50 (1.00 to 4.00)	1.25 (0.500 to 4.00)	4.00 (1.50 to 6.00)	3.50 (1.50 to 8.00)	3.00 (1.50 to 4.00)	3.00 (2.00 to 10.0)

Primary outcome: Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)

Time frame: 22 days. Geometric mean (95% Confidence Interval). Unit: μg·hr/mL

Measure	Allopurinol: Allopurinol Alone n = 12	Allopurinol: RDEA3170 + Allopurinol n = 12	Oxypurinol: Allopurinol Alone n = 12	Oxypurinol: RDEA3170 + Allopurinol n = 12	RDEA3170: RDEA3170 + Allopurinol n = 12
Value	3.69 (3.24 to 4.21)	3.68 (3.28 to 4.13)	255 (229 to 284)	157 (140 to 177)	115 (96.5 to 137)

Allopurinol: Allopurinol Alone vs Allopurinol: RDEA3170 + Allopurinol: Geometric Least Squares Mean Ratio (%): 102 (90% CI 93.3 to 111), Mixed Models Analysis
Oxypurinol: Allopurinol Alone vs Oxypurinol: RDEA3170 + Allopurinol: Geometric Least Squares Mean Ratio (%): 61.8 (90% CI 58.1 to 65.7), Mixed Models Analysis
RDEA3170: RDEA3170 + Allopurinol: Geometric Least Squares Mean Ratio (%): 95.9 (90% CI 88.4 to 104), Mixed Models Analysis

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

Time frame: 22 days. Geometric mean (95% Confidence Interval). Unit: μg·hr/mL

Measure	Allopurinol: Allopurinol Alone n = 12	Allopurinol: RDEA3170 + Allopurinol n = 12	Oxypurinol: Allopurinol Alone n = 12	Oxypurinol: RDEA3170 + Allopurinol n = 12
Value	3.50 (3.04 to 4.04)	3.61 (3.22 to 4.05)	255 (229 to 284)	157 (140 to 177)

Allopurinol: Allopurinol Alone vs Allopurinol: RDEA3170 + Allopurinol: Geometric Least Squares Mean Ratio (%): 103 (90% CI 94.9 to 112), Mixed Models Analysis
Oxypurinol: Allopurinol Alone vs Oxypurinol: RDEA3170 + Allopurinol: Geometric Least Squares Mean Ratio (%): 61.8 (90% CI 58.1 to 65.7), Mixed Models Analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 22 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RDEA3170 10 mg qd	0 of 12 (0%)	2 of 12 (16.7%)	Not reported
RDEA3170 10 mg qd + Allopurinol 300 mg qd	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
Allopurinol 300 mg qd	0 of 12 (0%)	3 of 12 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

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 10 mg and allopurinol 300 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 4 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 20 Dec 2017. 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?

Yes. Results are posted in the registry (first posted 20 Dec 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: 22 days). The study lists 12 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 NCT02279641.

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 20 Dec 2017.