Trial · NCT02279641

RDEA3170 and Allopurinol Combination Study in Gout Subjects

NCT02279641, Phase 1, Completed, Ardea Biosciences, Inc.; results first posted 2017-12-20

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. RDEA3170 and Allopurinol Combination Study in Gout Subjects. Trials, record NCT02279641. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02279641

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: RDEA3170 and Allopurinol Combination Study in Gout Subjects
NCT number: NCT02279641
Status: Completed
Phases: Phase 1
Enrollment: 12 participants, actual
Lead sponsor: Ardea Biosciences, Inc.
Conditions: Gout
Interventions: RDEA3170 10 mg, allopurinol 300 mg
First posted: 2014-10-31
Last updated: 2017-12-20
Results first posted: 2017-12-20

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Maximum Observed Plasma Concentration (Cmax)	22 days	μg/mL	GEOMETRIC_MEAN
PRIMARY	Time of Occurrence of Maximum Observed Concentration (Tmax)	22 days	hr	MEDIAN
PRIMARY	Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)	22 days	μg·hr/mL	GEOMETRIC_MEAN
PRIMARY	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)	22 days	μg·hr/mL	GEOMETRIC_MEAN
PRIMARY	Apparent Terminal Half-life (t1/2)	22 days	hr	GEOMETRIC_MEAN
PRIMARY	Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)	22 days	mg	GEOMETRIC_MEAN
PRIMARY	Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)	22 days	mL/min	GEOMETRIC_MEAN
PRIMARY	Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine	22 days	Percentage (%)	MEAN
SECONDARY	Incidence of Treatment-Emergent Adverse Events	22 days	Number of participants	NUMBER
PRIMARY	Maximum Observed Plasma Concentration (Cmax)	22 days	ng/mL	GEOMETRIC_MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group58

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximum Observed Plasma Concentration (Cmax)	Allopurinol: Allopurinol Alone	1.13	95% Confidence Interval 0.894 to 1.43	μg/mL
Maximum Observed Plasma Concentration (Cmax)	Allopurinol: RDEA3170 + Allopurinol	1.51	95% Confidence Interval 1.24 to 1.82	μg/mL
Maximum Observed Plasma Concentration (Cmax)	Oxypurinol: Allopurinol Alone	12.8	95% Confidence Interval 11.7 to 14.0	μg/mL
Maximum Observed Plasma Concentration (Cmax)	Oxypurinol: RDEA3170 + Allopurinol	8.68	95% Confidence Interval 7.99 to 9.43	μg/mL
Time of Occurrence of Maximum Observed Concentration (Tmax)	Allopurinol: Allopurinol Alone	1.50	Full Range 1.00 to 4.00	hr
Time of Occurrence of Maximum Observed Concentration (Tmax)	Allopurinol: RDEA3170 + Allopurinol	1.25	Full Range 0.500 to 4.00	hr
Time of Occurrence of Maximum Observed Concentration (Tmax)	Oxypurinol: Allopurinol Alone	4.00	Full Range 1.50 to 6.00	hr
Time of Occurrence of Maximum Observed Concentration (Tmax)	Oxypurinol: RDEA3170 + Allopurinol	3.50	Full Range 1.50 to 8.00	hr
Time of Occurrence of Maximum Observed Concentration (Tmax)	RDEA3170: RDEA3170 Alone	3.00	Full Range 1.50 to 4.00	hr
Time of Occurrence of Maximum Observed Concentration (Tmax)	RDEA3170: RDEA3170 + Allopurinol	3.00	Full Range 2.00 to 10.0	hr

1 to 10 of 58Source ClinicalTrials.gov

See all 58 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	RDEA3170 or Allopurinol Alone and in Combination (Sequence A)	6
Overall Study	STARTED	RDEA3170 or Allopurinol Alone and in Combination (Sequence B)	6
Overall Study	COMPLETED	RDEA3170 or Allopurinol Alone and in Combination (Sequence A)	6
Overall Study	COMPLETED	RDEA3170 or Allopurinol Alone and in Combination (Sequence B)	6
Overall Study	NOT COMPLETED	RDEA3170 or Allopurinol Alone and in Combination (Sequence A)	0
Overall Study	NOT COMPLETED	RDEA3170 or Allopurinol Alone and in Combination (Sequence B)	0

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	RDEA3170 10 mg qd	1	12	1
other	Diarrhoea	Gastrointestinal disorders	RDEA3170 10 mg qd + Allopurinol 300 mg qd	0	12	0
other	Diarrhoea	Gastrointestinal disorders	Allopurinol 300 mg qd	0	12	0
other	Toothache	Gastrointestinal disorders	RDEA3170 10 mg qd	0	12	0
other	Toothache	Gastrointestinal disorders	RDEA3170 10 mg qd + Allopurinol 300 mg qd	1	12	1
other	Toothache	Gastrointestinal disorders	Allopurinol 300 mg qd	0	12	0
other	Vomiting	Gastrointestinal disorders	RDEA3170 10 mg qd	1	12	1
other	Vomiting	Gastrointestinal disorders	RDEA3170 10 mg qd + Allopurinol 300 mg qd	0	12	0
other	Vomiting	Gastrointestinal disorders	Allopurinol 300 mg qd	0	12	0
other	Gastroenteritis	Infections and infestations	RDEA3170 10 mg qd	0	12	0

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	RDEA3170 10 mg qd
Total, all-cause mortality	RDEA3170 10 mg qd + Allopurinol 300 mg qd
Total, all-cause mortality	Allopurinol 300 mg qd
Total, other adverse events	RDEA3170 10 mg qd	2	12
Total, other adverse events	RDEA3170 10 mg qd + Allopurinol 300 mg qd	1	12
Total, other adverse events	Allopurinol 300 mg qd	3	12
Total, serious adverse events	RDEA3170 10 mg qd	0	12
Total, serious adverse events	RDEA3170 10 mg qd + Allopurinol 300 mg qd	0	12
Total, serious adverse events	Allopurinol 300 mg qd	0	12

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02279641

GET https://conductscience.org/api/trials/v1/NCT02279641/results?page=2

API reference For AI assistants