Phase 2
N=64
RDEA3170 and Febuxostat Combination Study in Gout Subjects
Gout
Bottom Line
View on ClinicalTrials.gov: NCT02246673 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Serum Urate Maximum Percentage (%) Change (Emax, CB) — -43.5; -55.6; -70.4; -79.1 Percentage (%) — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RDEA3170 15 mg (Drug); RDEA3170 10 mg (Drug); RDEA3170 2.5 (Drug); RDEA3170 5 mg (Drug); Febuxostat 40 mg (Drug); Febuxostat 80 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ardea Biosciences, Inc.
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Urate Maximum Percentage (%) Change (Emax, CB) |
-43.5; -55.6; -70.4; -79.1; -74.9; -82.4 | <0.0001 sig |
| PRIMARY Urine Uric Acid % Change (0-24h) (Aeur, CB) |
-48.6; -60.3; -23.7; -36.6; -22.9; -44.4 | 0.0002 sig |
| PRIMARY Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB) |
-15.2; -18.8; 125; 153; 157; 172 | <0.0001 sig |
| PRIMARY Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB) |
-20.6; -20.8; 100; 155; 133; 152 | <0.0001 sig |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
15.5; 16.1; 21.2; 20.4; 7.20; 7.54 | — |
| SECONDARY Time of Occurrence of Maximum Observed Concentration (Tmax) |
3.00; 3.00; 3.00; 4.00; 3.50; 4.00 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24) |
123; 138; 186; 225; 62.2; 57.6 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) |
123; 138; 186; 225; 62.2; 62.6 | — |
| SECONDARY Apparent Terminal Half-life (t1/2) |
8.26; 9.64; 10.6; 10.8; 13.2; 11.3 | — |
| SECONDARY Incidence of Treatment-Emergent Adverse Events |
3; 8; 4; 6; 1; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02246673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.