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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Serum Urate Maximum Percentage (%) Change (Emax, CB)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m
- •Screening serum urate level ≥ 8 mg/dL.
- •Free of any clinically significant disease or medical condition, per the Investigator's judgment.
排除标准
- •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.
研究组 & 干预措施
RDEA3170 10 mg
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.
干预措施: RDEA3170 10 mg (Drug)
RDEA3170 10 mg
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.
干预措施: Febuxostat 40 mg (Drug)
RDEA3170 10 mg
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.
干预措施: Febuxostat 80 mg (Drug)
RDEA3170 15 mg
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.
干预措施: RDEA3170 15 mg (Drug)
RDEA3170 15 mg
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.
干预措施: RDEA3170 5 mg (Drug)
RDEA3170 15 mg
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.
干预措施: Febuxostat 40 mg (Drug)
RDEA3170 15 mg
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.
干预措施: Febuxostat 80 mg (Drug)
RDEA3170 5 mg
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.
干预措施: Febuxostat 40 mg (Drug)
RDEA3170 5 mg
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.
干预措施: Febuxostat 80 mg (Drug)
RDEA3170 2.5 mg
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.
干预措施: RDEA3170 2.5 (Drug)
RDEA3170 2.5 mg
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.
干预措施: Febuxostat 40 mg (Drug)
RDEA3170 2.5 mg
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.
干预措施: Febuxostat 80 mg (Drug)
结局指标
主要结局
Serum Urate Maximum Percentage (%) Change (Emax, CB)
时间窗: 28 days
Maximum observed percentage (%) change from baseline in serum urate concentrations.
Urine Uric Acid % Change (0-24h) (Aeur, CB)
时间窗: 28 days
Percentage (%) change from baseline in the amount of uric acid recovered in urine.
Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)
时间窗: 28 days
Percentage (%) change from baseline in renal clearance of uric acid.
Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)
时间窗: 28 days
Percentage (%) change from baseline in fractional excretion of uric acid.
次要结局
- Incidence of Treatment-Emergent Adverse Events(10 weeks)
- Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)(Days 7 to 28)
- Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)(Days 7 to 28)
- Maximum Observed Plasma Concentration (Cmax)(Days 7 to 28)
- Time of Occurrence of Maximum Observed Concentration (Tmax)(Days 7 to 28)
- Apparent Terminal Half-life (t1/2)(Days 7 to 28)