Phase 2
Completed N=64
RDEA3170 and Febuxostat Combination Study in Gout Subjects
Source: ClinicalTrials.gov NCT02246673 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Serum Urate Maximum Percentage (%) Change (Emax, CB) — -43.5; -55.6; -70.4; -79.1 Percentage (%) — p=<0.0001
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.
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 | — |
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. Informational only — not medical advice.