Back to resultsRDEA3170 and Febuxostat Combination Study in Gout Subjects
Primary Purpose
Gout
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RDEA3170 15 mg
RDEA3170 10 mg
RDEA3170 2.5
RDEA3170 5 mg
Febuxostat 40 mg
Febuxostat 80 mg
Sponsored by
About this trial
This is an interventional treatment trial for Gout
Eligibility Criteria
Inclusion Criteria:
- Able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity.
- 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.
- Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 45 kg/m2.
- Screening serum urate level ≥ 8 mg/dL.
- Free of any clinically significant disease or medical condition, per the Investigator's judgment.
Exclusion Criteria:
- Unable to take colchicine for gout flare prophylaxis.
- History or suspicion of kidney stones.
- Any gastrointestinal disorder that affects motility and/or absorption.
- Unstable angina, New York Heart Association class III or IV heart failure, ischemic heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or subject is currently receiving anticoagulants.
- Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator.
- Estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight during the Screening period.
- Taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2 inhibitors; chronic and stable doses are permitted if doses are stable for at least 14 days prior to study medication dosing.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
RDEA3170 10 mg
RDEA3170 15 mg
RDEA3170 5 mg
RDEA3170 2.5 mg
Arm Description
Once daily (qd) with febuxostat 40mg (qd) for 7 days, and with febuxostat 80 mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
Outcomes
Primary Outcome Measures
Serum Urate Maximum Percentage (%) Change (Emax, CB)
Maximum observed percentage (%) change from baseline in serum urate concentrations.
Urine Uric Acid % Change (0-24h) (Aeur, CB)
Percentage (%) change from baseline in the amount of uric acid recovered in urine.
Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)
Percentage (%) change from baseline in renal clearance of uric acid.
Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)
Percentage (%) change from baseline in fractional excretion of uric acid.
Secondary Outcome Measures
Maximum Observed Plasma Concentration (Cmax)
Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Apparent Terminal Half-life (t1/2)
t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Incidence of Treatment-Emergent Adverse Events
Full Information
NCT ID
NCT02246673
First Posted
September 19, 2014
Last Updated
June 27, 2017
Sponsor
Ardea Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02246673
Brief Title
RDEA3170 and Febuxostat Combination Study in Gout Subjects
Official Title
A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Febuxostat Compared to Febuxostat Administered Alone in Adult Subjects With Gout
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardea Biosciences, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to febuxostat administered alone in adult subjects with gout.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RDEA3170 10 mg
Arm Type
Experimental
Arm Description
Once daily (qd) with febuxostat 40mg (qd) for 7 days, and with febuxostat 80 mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
Arm Title
RDEA3170 15 mg
Arm Type
Experimental
Arm Description
Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
Arm Title
RDEA3170 5 mg
Arm Type
Experimental
Arm Description
Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
Arm Title
RDEA3170 2.5 mg
Arm Type
Experimental
Arm Description
Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
Intervention Type
Drug
Intervention Name(s)
RDEA3170 15 mg
Intervention Type
Drug
Intervention Name(s)
RDEA3170 10 mg
Intervention Type
Drug
Intervention Name(s)
RDEA3170 2.5
Intervention Type
Drug
Intervention Name(s)
RDEA3170 5 mg
Intervention Type
Drug
Intervention Name(s)
Febuxostat 40 mg
Intervention Type
Drug
Intervention Name(s)
Febuxostat 80 mg
Primary Outcome Measure Information:
Title
Serum Urate Maximum Percentage (%) Change (Emax, CB)
Description
Maximum observed percentage (%) change from baseline in serum urate concentrations.
Time Frame
28 days
Title
Urine Uric Acid % Change (0-24h) (Aeur, CB)
Description
Percentage (%) change from baseline in the amount of uric acid recovered in urine.
Time Frame
28 days
Title
Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)
Description
Percentage (%) change from baseline in renal clearance of uric acid.
Time Frame
28 days
Title
Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)
Description
Percentage (%) change from baseline in fractional excretion of uric acid.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax)
Description
Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time Frame
Days 7 to 28
Title
Time of Occurrence of Maximum Observed Concentration (Tmax)
Description
Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time Frame
Days 7 to 28
Title
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
Description
AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time Frame
Days 7 to 28
Title
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
Description
AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time Frame
Days 7 to 28
Title
Apparent Terminal Half-life (t1/2)
Description
t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time Frame
Days 7 to 28
Title
Incidence of Treatment-Emergent Adverse Events
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity.
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.
Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 45 kg/m2.
Screening serum urate level ≥ 8 mg/dL.
Free of any clinically significant disease or medical condition, per the Investigator's judgment.
Exclusion Criteria:
Unable to take colchicine for gout flare prophylaxis.
History or suspicion of kidney stones.
Any gastrointestinal disorder that affects motility and/or absorption.
Unstable angina, New York Heart Association class III or IV heart failure, ischemic heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or subject is currently receiving anticoagulants.
Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator.
Estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight during the Screening period.
Taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2 inhibitors; chronic and stable doses are permitted if doses are stable for at least 14 days prior to study medication dosing.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Hall
Organizational Affiliation
Ardea Biosciences, Inc.
Official's Role
Study Director
Facility Information:
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32951150
Citation
Rekic D, Johansson S, Leander J. Higher Febuxostat Exposure Observed in Asian Compared with Caucasian Subjects Independent of Bodyweight. Clin Pharmacokinet. 2021 Mar;60(3):319-328. doi: 10.1007/s40262-020-00943-6. Epub 2020 Sep 19.
Results Reference
derived
PubMed Identifier
29657831
Citation
Fleischmann R, Winkle P, Hall J, Valdez S, Liu S, Yan X, Hicks L, Lee C, Miner JN, Gillen M, Hernandez-Illas M. Pharmacodynamic and pharmacokinetic effects and safety of verinurad in combination with febuxostat in adults with gout: a phase IIa, open-label study. RMD Open. 2018 Apr 9;4(1):e000647. doi: 10.1136/rmdopen-2018-000647. eCollection 2018.
Results Reference
derived
Learn more about this trial
RDEA3170 and Febuxostat Combination Study in Gout Subjects
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